Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Ureteral Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Ureteral Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Antibodies

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Participants received either 75 milligrams per square meter (mg/m\^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 1 hour on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Eligible participants from chemotherapy arm who met the criteria for COE will receive 1.25 mg/kg of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle until discontinuation criteria is met.

Enfortumab Vedotin

Vinflunine

Medical Director

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.

Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier.

PFS: time from date of randomization until date of documented radiological disease progression (PD) per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow-up for PFS was based on data cut-off \& is same as median follow-up time for OS.

ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. ORR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for ORR was based on data cut-off and is same as median follow-up time for OS.

DCR was defined as the percentage of participants with a CR, PR or a stable disease (SD) based on RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease is defined in PFS1 endpoint. DCR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for DCR was based on data cut-off and is same as median follow-up time for OS.

DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by investigator to the date of documented PD or death due to any cause whichever occurred first. If a participant has neither progressed nor died, the participant was censored at the date of last RA or at the date of first CR/PR if no subsequent post-baseline RA was available. Participants who received any further ACT for the disease before radiological progression were censored at the date of the last RA before the ACT started. In addition, participants who had PD/death after \>= 2 missed RAs were censored at the last RA prior to the 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow up for DOR was based on data cut-off and is same as median follow-up time for OS. CR/PR and PD were defined in ORR and PFS1 endpoints, respectively.

EORTC QLQ-C30 is a generic questionnaire consisting of 30 items. The instrument yields functional scales (physical, role, emotional, cognitive, social), symptom scales/items (fatigue, Nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), global health status, and financial impact score. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). The recall period for each question is "during the past week". All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Higher scores on the global health status and functioning scales indicate better health status/function.

EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable).

An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is defined as an AE observed or worsened after starting administration of the study drug.

ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5. Dead. Number of participants with ECOG PS was reported.

Seagen Inc.

Astellas Pharma Global Development, Inc.

Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Chemotherapy

Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Enfortumab Vedotin 1.25 mg/kg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

ECOG PS=0

ECOG PS=1

ECOG PS was measured on 6 point scale 0-Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature
2. Ambulatory \& capable of all self-care but unable to carry out any work activities.Up \& about more than 50% of waking hours
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5. Dead Participants were categorized based on ECOG PS 0 or 1

ECOG PS

Liver Metastasis=No

Liver Metastasis=Yes

Participants were categorized based on liver metastasis (yes or no).

Liver Metastasis

Western Europe

United States

Rest of the World

Participants were categorized based on region western europe, US and rest of the world.

Region

The full analysis set (FAS) consisted of all participants who were randomized.

Clinical Trial Disclosure

Overall Survival (OS)

Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Response Evaluable Set (RES): The RES was defined as all participants in the FAS who had measurable disease (per RECIST v1.1) per investigator at baseline.

Overall Response Rate (ORR) as Per RECIST V1.1

Disease Control Rate (DCR) as Per RECIST V1.1

Duration of Response (DOR) as Per RECIST V1.1

Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)

Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The safety analysis set (SAF) consisted of all participants who received any amount of study drug, and was used for safety analyses.

Number of Participants With Treatment Emergent Adverse Events

ECOG PS = 0

ECOG PS = 1

ECOG PS >1

Number of Participants With ECOG Performance Status

Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Enfortumab Vedotin 1.25mg/kg

Participants received either 75 milligram per square meter (mg/m\^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Overall Study

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Urethral Cancer

Atezolizumab

Guadecitabine

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients will be administered atezolizumab intravenously on day 1 and day 22 of a 6 week cycle for the period of 8 cycles.

Guadecitabine will be administered subcutaneously on days 1 through 5 of the 6 week cycle for the period of 4 cycles

This is a single arm Phase II study with a safety run-in to identify the recommended phase II dose of the combination therapy of atezolizumab and guadecitabine. Patients with recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this study. After a dose that is safe and tolerable has been established, a dose expansion phase (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the number of patients treated in the safety run-in phase and the number of subjects replaced during the phase II portion.

Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma

GU-114: Overcoming Checkpoint Inhibitor Resistance With Epigenetic Therapy in Urothelial Cancer

Dose de-escalation study based on standard 3+3 design will be conducted to test two dose levels of guadecitabine: 45mg/m2 and 36mg/m2 to determine MTD

Stand Up To Cancer

Van Andel Research Institute

Fox Chase Cancer Center

Vaccines

Immunomodulating Agents

Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

DN24-02

Observation only until documentation of disease recurrence.

Standard of Care

Robert Israel, MD

This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

Overall survival is defined as the time from randomization to death due to any cause.

\*This study was terminated early due to administrative reasons.

Dendreon

Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Age, Categorical

Region of Enrollment

Baseline weight for one subject in standard of care group is missing.

Body weight

ECOG 0=Fully Active; No restrictions

ECOG 1= Restricted Strenuous Activity

ECOG 2=Ambulatory, capable of self-care; no work

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Baseline ECOG data is missing for one subject in each group.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Shabnam Vaziri

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Standard of Care: Standard of care

Intent to Treat (ITT) population.

\*This study was terminated early due to administrative reasons.

Overall Survival

Symptoms and General Pathology

Prostatic Neoplasms

Carcinoma, Renal Cell

Kidney Calculi

Nephrolithiasis

Kidney Neoplasms

Calculi

Kidney Diseases

Urolithiasis

Urinary Calculi

Pathological Conditions, Anatomical

Renal Cell Carcinoma

telerounding versus bedside rounding

Lars Ellison, MD

Telerounding is the use of wireless remote video-confrencing to assess hospitalized patients. Physicians thus rely on all ususal data collected during bedside rounds with the exeption of a direct physical exam. The intention of this study is to determine if post-operative morbidity can be identified in an accurate and timely manner.

Design: Two hundred seventy patients were recruited from three sites into a prospective multi-center randomized trial. Participating institutions were the University of California, Davis Medical Center (Sacramento CA), Johns Hopkins Hospital (Baltimore MD) and Sentara Health (Norfolk VA). Internal Review Board approval was granted at each institution independently. The study population consisted of patients scheduled for urologic surgery, over age 18, and able to read and understand English. Patients undergoing the following laparoscopic procedures were offered participation: nephrectomy, partial nephrectomy, nephroureterectomy, retroperitoneal lymph node dissection, partial ureterectomy, and radical prostatectomy. Patients had an expected hospital stay of 24 to 72 hours. Eligible patients who were unable to provide consent or who do not wish to participate in the study received the standard of care provided at each institution. A total of two hundred seventy patients consented to participation.

Randomization: A stratified block scheme was used for randomization. Participating patients were randomized to either: standard daily bedside rounding by the attending surgeon (control arm), or daily telerounding only by the attending surgeon (intervention arm).

Outcome Measures: The primary outcome measure was differences in rates of attending surgeon-identified complications between standard rounds and telerounds. The secondary outcome measures included differences in length of stay and patient reported satisfaction with their hospitalization.

Protocol: Consenting patients had their scheduled surgery and received the standard peri-operative and immediate post-operative care. All patients were managed with a rapid recovery protocol. This included: liquid diet beginning twelve hours after surgery with immediate advancement as tolerated; complete blood count, serum electrolytes, BUN and creatnine in the recovery room and each morning until discharge; and usual nursing data recorded each shift. These data points included oral temperature, blood pressure, pulse, respiratory rate, fluid intake, fluid output, and pain scale Once transferred to the patient floor, all patients communicated with their attending physician on a daily basis. The visit, either at the bedside or via telerounds followed a set scripting. The visit was conducted between the patient and the attending without other staff present. The focus of the visit was review of objective data (vital signs, fluid balances and laboratory values), subjective data (cursory abdominal exam if at the bedside and evaluation of drain effluent) and a discussion of the anticipated goals for the day. Visit duration was timed. Intervention patients could remove themselves from the study at any time by requesting a bedside visit by the attending physician. Telerounding concluded with either the hospital discharge or identification of a major post-operative complication.

Definitions: A major complication was defined as an event that required transfer to a monitored setting. Minor complications included events that delay discharge greater than 24 hours beyond the expected length of stay. For example (but not limited to): post-operative ileus, drop in hematocrit, prolonged drain output or fever Event monitoring: Identification of complications was recorded prospectively. Usual resident-level bedside rounds were maintained throughout the study. The resident team and the attending surgeon recorded identified events independently, thus allowing for evaluation of concordance. This dual rounding design served as a minimally acceptable standard as stipulated by the various internal review boards. As a precondition of IRB approval, identification of an event required notification of the attending surgeon in a timely fashion.

Instrument: We utilized a validated 21-item questionnaire to evaluate patient ratings of their hospital care. Items regarding postoperative care were designed using an extensively tested and validated response scale (1, poor to 5, excellent). Item stems were modified from Patient Judgments of Hospital Quality to make them more salient to the postoperative experience. Five items asked patients to rate their baseline health status as well as their health status during the hospitalization. Seven items asked patients to evaluate aspects of the care they received while an in-patient. Nine items asked those randomized to the telerounding arm to evaluate the telecommunications system and to indicate their level of interest in having this system incorporated into usual post-operative care.

Device: The telerounding robot is a 60-inch tall wheel driven device. The robot consists of the motor base unit, Pentium III CPU, high definition digital camera, flat screen monitor and microphone. Data to and from the robot is transferred over a high-speed wireless network and integrated with proprietary software. The physician connects remotely to the robot via a base station. The base station consists of a Pentium III desktop computer, high definition digital camera, flat screen monitor, microphone and joystick controller. Each of the institutions used identical technology. Prior testing of the system demonstrated imperceptible video and audio delay.

Analytic Plan: The primary endpoint of the study is patient morbidity. The expected rate of complication (major and minor) after a laparoscopic urologic procedure is 16%. Based on our power calculation, a total of 270 patients (135 in each arm) were required to detect a 1% difference in complication at the 0.05 alpha level and the 0.8 beta level. Continuous variables were compared using student T-test. Proportions were compared using chi-square analysis. Logistic regression was reserved for adjustments based on observed statistical differences in baseline demographic data.

Postoperative Telerounding: A Multi-Center Prospective Randomized Assessment of Patient Outcomes and Satisfaction.

Remote Post-Operative Rounding and the Physician Ability to Identify Morbidity

University of California, Davis

Pelvic Neoplasms

Urethral Neoplasms

Urethral Diseases

Anti-Infective Agents

Gemcitabine

Doxorubicin

Liposomal doxorubicin

Bortezomib

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Starting dose of Bortezomib 0.8 mg/m\^2 IV Over 3-5 Seconds. Starting dose of Gemcitabine 225 mg/m\^2 IV Up to 90 Minutes. Starting dose of Doxorubicin 12.5 mg/m\^2 IV Over 15-30 minutes.

Starting dose: 0.8 mg/m\^2 IV Over 3-5 Seconds

Starting dose: 225 mg/m\^2 IV Up to 90 Minutes

Starting dose: 12.5 mg/m\^2 IV Over 15-30 minutes

Arlene Siefker-Radtke, MD

The goal of this clinical research study is to find the highest tolerable dose of Gemzar® (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade® (bortezomib) in patients with urothelial cancer or other solid tumors.

Gemcitabine and doxorubicin are designed to disrupt the growth of cancer cells, which causes cancer cells to start to die. Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide. This helps to kill the tumor cells.

If you are found to be eligible to take part in this study, you will receive doses of the study drugs based on when you join the study and how many people have started before you. Two (2) participants will be entered into each dose level. Additional participants may be added at a dose level if it is being well tolerated. The doses will increase until the highest tolerable dose is found.

You will receive the 3 study drugs on the first day of each cycle. You will receive gemcitabine for up to 90 minutes. Next you will receive doxorubicin over 15-30 minutes. Bortezomib will be given last over 3-5 seconds. Every 14 days is considered a study "cycle."

While on study, you will have a complete physical exam before each dose of study drugs. Blood (about 3 teaspoons) will be drawn to check bone marrow and kidney function each week during the first month. The study doctor may decide to draw blood more often, if you are having side effects to the study drugs. Your vital signs will be measured before you receive the study drugs and 1 hour after the infusion.

At the end of Cycle 3, your tumor status will be re-evaluated. You will have CT scans and a bone scan. Blood (about 2 tablespoons) will be drawn for routine tests.

You will be taken off study if the disease gets worse or intolerable side effects occur. If you have stable disease, you may continue receiving therapy as long as your physician feel you are benefiting.

Once you are off-study, you will receive a phone call every 6 months. You will be asked how you are doing, the status of the disease, and if you have had other treatments.

This is an investigational study. Gemcitabine, doxorubicin, and bortezomib are all FDA approved and commercially available. Their use in this study is considered investigational because they have not been approved in patients with urothelial cancer. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors

Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination With Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors

Participants be assessed for response on the basis of conventional response criteria for urothelial cancer.

Tumor status re-evaluated by CT scans and a bone scan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)	NCT03474107	Ureteral Cancer Urothelial Canc... Bladder Cancer	Enfortumab Vedo... Docetaxel Vinflunine Paclitaxel	18 Years -	Astellas Pharma Inc
Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma	NCT03179943	Urothelial Carc...	Atezolizumab Guadecitabine	18 Years -	Fox Chase Cancer Center
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon
Postoperative Telerounding: A Multi-Center Prospective Randomized Assessment of Patient Outcomes and Satisfaction.	NCT00263107	Kidney Cancer Ureteral Cancer Prostate Cancer Nephrolithiasis	telerounding ve...	18 Years -	University of California, Davis
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors	NCT00479128	Solid Tumor Urethral Cancer	Bortezomib Gemcitabine Doxorubicin	-	M.D. Anderson Cancer Center
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon

Spots Global Cancer Trial Database for ureteral cancer