Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Hormones

Zoledronic Acid

Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.

Patients receive zoledronate as in Arm I.

rebimastat

zoledronic acid

laboratory biomarker analysis

Roberto Pili

Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity profile associated with this treatment in this patient population.

II. To evaluate the overall and progression-free survival associated with this treatment regimen.

III. To explore changes markers for bone turnover, fPYR, fDPYR, and serum samples for cross-linked N-telopeptides from baseline.

IV. To assess changes in bone tumor metabolism after treatment using PET scans. V. To assess changes in MMP-1, MMP-9, VEGF and bFGF from baseline after treatment.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.

ARM I: Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.

ARM II (CLOSED TO ACCRUAL AS OF 10/10/2003): Patients receive zoledronate as in Arm I.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer

A Phase II, Open-Label, Randomized Trial of Zoledronic Acid (Zometa™) and BMS-275291 (NSC#713763) in Patients With Hormone Refractory Prostate Cancer

The distribution of survival time will be estimated using the method of Kaplan-Meier.

The distribution of time to progression will be estimated using the method of Kaplan-Meier.

The distribution of this response duration will be estimated using the method of Kaplan-Meier.

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

National Cancer Institute (NCI)

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

carboplatin

paclitaxel

Michael Smylie, MD, MB, ChB

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin are more effective with or without BMS-275291 for non-small cell lung cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of paclitaxel and carboplatin with or without BMS-275291 in treating patients who have advanced or metastatic non-small cell lung cancer.

OBJECTIVES:

* Compare the overall survival of patients with advanced or metastatic non-small cell lung cancer treated with paclitaxel and carboplatin with or without BMS-275291.
* Compare the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in patients treated with these regimens. (Phase II only)
* Compare the objective tumor response rate, time to response, and response duration in patients treated with these regimens.
* Compare the nature, severity, and frequency of toxic effects of these regimens in these patients.
* Compare the progression free survival of patients treated with these regimens. (Phase III only)
* Correlate the expression of serum/plasma and tissue matrix metalloproteinases (MMP) levels and other markers with outcomes and response in patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center, disease stage (IIIB vs IV), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 plus oral BMS-275291 daily on days 1-21.
* Arm II: Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily on days 1-21.

Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. BMS-275291 or placebo continues beyond 8 courses in the absence of disease progression.

Quality of life is assessed.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 776 patients will be accrued for this study within 27 months.

Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer

A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

NCIC Clinical Trials Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer	NCT00039104	Adenocarcinoma ... Recurrent Prost... Stage IV Prosta...	rebimastat zoledronic acid laboratory biom...	18 Years -	National Cancer Institute (NCI)
Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer	NCT00006229	Lung Cancer	carboplatin paclitaxel rebimastat	18 Years - 120 Years	Canadian Cancer Trials Group
Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer	NCT00006229	Lung Cancer	carboplatin paclitaxel rebimastat	18 Years - 120 Years	Canadian Cancer Trials Group
Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer	NCT00039104	Adenocarcinoma ... Recurrent Prost... Stage IV Prosta...	rebimastat zoledronic acid laboratory biom...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for rebimastat

Every month we try and update this database with for rebimastat 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 rebimastat

Every month we try and update this database with for rebimastat 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 rebimastat 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.