Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Vasodilator Agents

Urological Agents

Anticoagulants

Other Dietary Supplements

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Sildenafil Citrate

Citric Acid

Sodium Citrate

Tubulin Modulators

Antimitotic Agents

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

Sildenafil plus carboplatin and weekly paclitaxel

sildenafil

placebo

paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days

paclitaxel (taxol)

carboplatin; AUC=6 on day 1, every 28 days

carboplatin (palaplatin)

Kingo Chida, MD,PhD

A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Randomized Phase II Study of Combination Chemotherapy With Sildenafil Plus Carboplatin and Weekly Paclitaxel in Patients With Previously Untreated Advanced Non-small Cell Lung Cancer

Hamamatsu University

Department of Respiratory Medicine

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Bryostatin 1

Adjuvants, Immunologic

Immunologic Factors

40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).

Bryostatin-1

80 mg/m\^2 one-hour infusion weekly x 3 every 4 weeks

Paclitaxel (Taxol)

Jaffer A. Ajani, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.

OBJECTIVES:

* Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel.
* Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer

A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.

Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.

Ixabepilone (Ixempra)

Denise A Yardley, M.D.

This is a randomized, Phase III, open-label, multicenter study.

Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.

A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer

Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer

The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.

The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.

Bristol-Myers Squibb

SCRI Development Innovations, LLC

Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Ixabepilone (Ixempra): 40 mg/m2

Ixabepilone

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Paclitaxel (Taxol): 80 mg/m2

Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.

Doxorubicin: 60 mg/m2

Cyclophosphamide: 600 mg/m2

Paclitaxel (Taxol): 80 mg/m2

Total

<50 years

≥50 years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Premenopausal

Postmenopausal

Menopausal Status

Analyses of baseline characteristics, demographics and efficacy includes all randomized patients.

Charles H. Davis, RAC

3-year DFS

5-year DFS

The intent-to-treat population (all randomized patients) are included in the analysis.

Disease-free Survival

3-year OS

5-year OS

Overall Survival

Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).

Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2

AC/Ixabepilone

Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.

Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2

AC/Paclitaxel

AC Therapy

Adjuvant Therapy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Squamous Cell

Penile Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Penile Diseases

Male Urogenital Diseases

Penile Cancer

Cisplatin

Ifosfamide

Isophosphamide mustard

Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1

1200 mg/m\^2 By Vein Over 2 Hours on Days 1-3

175 mg/m\^2 By Vein Over 3 Hours on Day 1

25 mg/m\^2 By Vein Over 2 Hours on Days 1-3

Lance Pagliaro, MD

Primary Objective:

-To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell carcinoma of the penis.

Before treatment starts, participants will have a complete exam, including blood and urine tests. A CT scan of the abdomen and pelvis will be done. Participants will have a chest x-ray, bone scan, and an EKG (heart test). A special heart function test may also need to be done in some participants. If necessary a biopsy of enlarged lymph node(s) will be obtained prior to treatment.

Blood tests will be repeated once a week during treatment. CT scans of the abdomen and pelvis and a Chest x-ray will be done after 2 treatments with Taxol, Ifosfamide, and Cisplatin. These will also be done before surgery.

The drugs Taxol, Ifosfamide and Cisplatin will be given through a catheter (plastic tube) placed in a vein in the arm or under the collarbone. Taxol will be given over 3 hours the first day of the treatment cycle. To prevent an allergic reaction, before the Taxol is given, the participant will receive three drugs. These are Dexamethasone, Diphenhydramine, and either Cimetidine or Ranitidine.

After Taxol, Ifosfamide will be given over 2 hours every day for the first three days of the treatment cycle. To prevent possible irritation of Ifosfamide to the bladder, participants will also receive Mesna through the plastic catheter. Mesna will be given both before and after Ifosfamide every day. Mesna is not chemotherapy. It is a medication to prevent side effects of Ifosfamide into the bladder.

Every day for the first three days of the cycle, and after Ifosfamide is given, participants will also receive Cisplatin through the catheter at a steady rate over 2 hours, along with Mannitol and salt water to flush the kidneys. This treatment will be given in the hospital and will require staying in the hospital for 3-4 days. It will be repeated for a total of 4 times; once every 21 days, if the participant has high enough numbers of white blood cells and platelets.

Participants may be given injections of G-CSF under the skin once a day for up to 7 days (days 6-12 of the cycle) to bring the white cells up faster after the chemotherapy. This will also lower the risk of severe infections.

After completing 4 treatments of chemotherapy, participants will have blood and urine tests, a chest x-ray to learn the response of the tumor to the chemotherapy. They will also have a CT scan of the abdomen and pelvis. Participants who have a response to the chemotherapy, or show no sign of new spread of the cancer to other parts of the body, will then have surgery. Surgery will be done to remove the tumor. The lymph nodes in the groin will be removed. The pelvic lymph nodes may also need to be removed. How much tissue is removed depends on how far the tumor has spread. The surgeons will explain the specifics of the surgery in a separate consent form.

After completion of the treatment, physical exams, CT scans, chest x-rays, blood tests, and urine tests will be done every 3 months for 2 years. They will then be done every 6 months. These procedures can be done by a physician at M. D. Anderson or by the participant's own doctor. If the participant's doctor does it, the information will need to be forwarded to the doctors at M. D. Anderson. Participants will be expected to come to M. D. Anderson or to their respective participating urologist/medical oncologist at least once every 6 months for a check-up.

This is an investigational study. The FDA has approved Taxol, Ifosfamide, Cisplatin, and Mesna. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis

Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.

Cisplatin + Ifosfamide + Paclitaxel

Age Continuous

United States

Region of Enrollment

Cherie A. Perez

Participants who completed chemotherapy without progression then had surgical resection.

Number of Participants With Pathologic Complete Remission (pCR)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer	NCT00752115	Non-small Cell ...	sildenafil placebo paclitaxel (tax... carboplatin (pa...	40 Years - 75 Years	Hamamatsu University
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer	NCT00006081	Esophageal Canc... Gastric Cancer	Bryostatin-1 Paclitaxel (Tax...	18 Years -	M.D. Anderson Cancer Center
A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer	NCT00789581	Breast Cancer	Doxorubicin Cyclophosphamid... Ixabepilone (Ix... Paclitaxel (Tax...	18 Years -	SCRI Development Innovations, LLC
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer	NCT00752115	Non-small Cell ...	sildenafil placebo paclitaxel (tax... carboplatin (pa...	40 Years - 75 Years	Hamamatsu University
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer	NCT00006081	Esophageal Canc... Gastric Cancer	Bryostatin-1 Paclitaxel (Tax...	18 Years -	M.D. Anderson Cancer Center
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer	NCT00006081	Esophageal Canc... Gastric Cancer	Bryostatin-1 Paclitaxel (Tax...	18 Years -	M.D. Anderson Cancer Center
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis	NCT00512096	Penile Cancer	Ifosfamide Paclitaxel (Tax... Cisplatin	14 Years -	M.D. Anderson Cancer Center
A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer	NCT00789581	Breast Cancer	Doxorubicin Cyclophosphamid... Ixabepilone (Ix... Paclitaxel (Tax...	18 Years -	SCRI Development Innovations, LLC
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis	NCT00512096	Penile Cancer	Ifosfamide Paclitaxel (Tax... Cisplatin	14 Years -	M.D. Anderson Cancer Center
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer	NCT00006081	Esophageal Canc... Gastric Cancer	Bryostatin-1 Paclitaxel (Tax...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for paclitaxel (taxol)