Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Sorafenib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.

Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months. The total chemotherapy dose for gemcitabine and cisplatin (GC) may be modified for patients with severe obesity (e.g. body surface area (BSA) \> 2.1), after consultation with the Principal Investigator.

gemcitabine and cisplatin plus sorafenib

Matthew Milowsky, MD

Standard chemotherapy drugs generally work by killing rapidly dividing cells in your body. Cancers cells are some of the most rapidly dividing cells and that is why chemotherapy can be effective in some patients. Gemcitabine and Cisplatin are an effective and standard drug combination used to treat locally advanced and metastatic urothelial cancer. However, these drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.

New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Sorafenib is an example of a drug that works in this way.

In some patients with advanced kidney cancer, sorafenib alone has been shown to slow the progression of their disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, cisplatin, and sorafenib has on you and your cancer.

Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Phase II Study of Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Bayer

Memorial Sloan Kettering Cancer Center

This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.

Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months.

Gemcitabine and Split-dose Cisplatin + Sorafenib

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to no subjects analyzed. Only two participants were enrolled and treated on this study. Neither completed the study as they both came off due to adverse events.

Dr. Dean Bajorin

To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Carcinoma in Situ

Anti-Infective Agents

Everolimus

BCG Vaccine

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response. Patients demonstrating a CR (by cystoscopy and cytology) or a Partial Response at their Cycle 12 cystoscopy will be observed with serial cystoscopies every 3 months.

Phase I: Everolimus will be adm as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be adm at 10 mg daily the dose determined in Phase I. Pts will receive a dose of 2000 mg of intravesical gemcitabine twice a week (72-96 +8 hours between doses) for 3 weeks for a total of 6 treatments in course 1. After 1 week of rest from intravesical gemcitabine, course 2 will be administered, provided the treating physician notes acceptable pt tolerance. The total number of intravesical instillations will be 12. There will be no dose modifications to gemcitabine; however, pts will be allowed to skip gemcitabine doses if needed, per the treating physician's discretion. Missed or skipped doses of gemcitabine will not be repeated. The pt will receive as many instillations as tolerable up to the maximum of 12 instillations.

Everolimus and Intravesical Gemcitabine

Guido Dalbagni, MD

The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.

RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

Phase I/II Study of RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

Everolimus (mg) given in conjunction with intravesical gemcitabine

of Everolimus given in conjunction with intravesical gemcitabine

Complete Response (CR) is defined as no evidence of disease (by cytology and cystoscopy). Partial Response is defined as negative cystoscopy and positive cytology. Progression is defined as the development of invasion or metastasis. If the participant develops a recurrence, they will be considered having failed treatment. Participants will also be considered having failed treatment if there is no response to treatment after two cycles.

With Everolimus in combination with intravesical gemcitabine. Overall survival following start of therapy will be estimated using Kaplan-Meier methods.

In all pre-treatment specimens and analysis of post treatment specimens when available.

Novartis Pharmaceuticals

New York University

University of Hawaii

Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase I.

Pts Who Failed or Relapsed After Intravesical BCG

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Guido Dalbagni

14 of the 33 participants were enrolled in the Phase I portion of the protocol

Phase I - Dose-limiting Toxicity (DLT)

19 participants were evaluable for Phase II.

Phase II - Patients Who Are Free of Disease at 1 Year

Phase I - Maximum Tolerated Dose (MTD)

Complete Response

Partial Response

Did not achieve CR or PR

Complete Response (CR) Rate

Survival of Patients Treated

Inability for sequencing due to inadequate amount of tissue

Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation

Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response.

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Micronutrients

Hematinics

Vitamins

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

10-deazaaminopterin

Aminopterin

Trace Elements

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Vitamin B12 : 1 mg intramuscular injection Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

Folic Acid: 1-1.25 mg orally Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.

Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).

Initial dose: 190 mg/m2

Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.

Pralatrexate Injection

1 mg intramuscular injection

Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

1-1.25 mg orally

Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.

Garry Weems, Pharm.D.

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)

Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.

The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)

Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan, whichever indicates PD) or death, regardless of cause.

The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.

Acrotech Biopharma Inc.

Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.

Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.

Full Population

France

Argentina

Spain

Belgium

Medical Monitor

All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (\> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.

Evaluable Population

Objective Response Rate (ORR)

All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (\> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.

Evaluable Patients

Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)

Duration of Response (DOR)

Clinical Benefit Rate (CBR)

Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.

Progression Free Survival (PFS)

Analysis per protocol. Patients who had not died or were lost to follow-up were censored

Overall Survival (OS)

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Amino Acids

Eflornithine

Sulindac

Antiprotozoal Agents

Antiparasitic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Ornithine

Sulindac alone, washout, DFMO alone, then combination of sulindac and DFMO

DFMO alone, followed by washout, sulindac alone, then combination of DFMO and sulindac

500 mg oral for 14 days, combined with sulindac for 15 days

difluoromethylornithine

150 mg oral for 15 days, combined with DFMO for 14 days

The purpose of this study is to determine the effects of 2 drugs (sulindac and Difluoromethylornithine (DFMO)) either alone or in combination on biomarkers found in urine.

Urinary Biomarker Study With Sulindac and Difluoromethylornithine

A Phase 2 Urinary Biomarker Study of Polyamine Inhibition With Sulindac and Difluoromethylornithine (DFMO)

Measure initial variability in levels of urinary biomarkers prior to initiation of drug treatment. Three blood draws over the first 14 days will be used to assess baseline variability.

Measure urinary biomarker dcSAM after 14 days of single agent DFMO. Measure urinary biomarker dcSAM after 14 days of single agent DFMO for treatment arm where DFMO alone is started week 2 (Treatment sequence A).

Measure urinary biomarker dcSAM after 14 days of single agent sulindac. Measure urinary biomarker dcSAM after 14 days of single agent sulindac for treatment arm where sulindac alone is started week 2 (Treatment sequence B).

Measure urinary biomarker dcSAM after 14 days of single agent DFMO for treatment arm where DFMO alone is started week 10 (Treatment sequence B)

Measure urinary biomarker dcSAM after 14 days of single agent sulindac. Measure urinary biomarker dcSAM after 14 days of single agent sulindac for treatment arm where sulindac alone is stated week 10 (Treatment sequence A).

Quantitate dietary polyamine levels over the course of the study and evaluate the effects on biomarkers evaluated in the primary outcome measures.

University of Arizona

Cancer Prevention Pharmaceuticals, Inc.

Associate Professor, Cellular and Molecular Medicine

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.

Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.

cisplatin 35 mg/m\^2 will be administered intravenously on days 1 and 8.

cisplatin

Dean Bajorin, MD

The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your tumor before you undergo surgery for your bladder cancer.

Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.

is defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.

The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.

Pfizer

This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.

Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.

Gemcitabine, Cisplatin, and Sunitinib

Dr. M. Catherine Pietanza

The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.

The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.

The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma	NCT00714948	Bladder Cancer URINARY BLADDER	gemcitabine and...	18 Years -	Memorial Sloan Kettering Cancer Center
RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder	NCT01259063	Bladder Cancer	Everolimus and ...	18 Years -	Memorial Sloan Kettering Cancer Center
Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma	NCT00714948	Bladder Cancer URINARY BLADDER	gemcitabine and...	18 Years -	Memorial Sloan Kettering Cancer Center
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder	NCT00722553	Carcinoma, Tran... Bladder Cancer Bladder Neoplas...	Pralatrexate In... Vitamin B12 Folic Acid	18 Years -	Acrotech Biopharma Inc.
Urinary Biomarker Study With Sulindac and Difluoromethylornithine	NCT01636128	Focus of Study:...	difluoromethylo... Sulindac	40 Years - 65 Years	Cancer Prevention Pharmaceuticals, Inc.
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer	NCT00847015	Bladder Cancer Urinary Bladder	Sunitinib Gemcitabine cisplatin	18 Years -	Memorial Sloan Kettering Cancer Center
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder	NCT00722553	Carcinoma, Tran... Bladder Cancer Bladder Neoplas...	Pralatrexate In... Vitamin B12 Folic Acid	18 Years -	Acrotech Biopharma Inc.
RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder	NCT01259063	Bladder Cancer	Everolimus and ...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for urinary

Every month we try and update this database with for urinary cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for urinary

Every month we try and update this database with for urinary cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for urinary cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.