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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00942331 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Prostate Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Biological: bevacizumab Drug: cisplatin Drug: gemcitabine hydrochloride Drug: placebo administration |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: cisplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: placebo administration
Given IV
|
|
Experimental: Arm II
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: cisplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to presence of visceral (lung, liver, bone, splenic, or intra-abdominal) metastases (no vs yes) and prior chemotherapy (including adjuvant therapy, neoadjuvant therapy, and single-agent radiosensitizers) (no vs yes). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed up periodically for up to 7 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed transitional (urothelial) cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra)
PATIENT CHARACTERISTICS:
No arterial thrombotic events within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior combination systemic chemotherapy for metastatic disease
Contacts and Locations
Show 497 Study Locations| Study Chair: | Jonathan Rosenberg, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00942331 History of Changes |
| Other Study ID Numbers: | CDR0000649174, CALGB-90601 |
| Study First Received: | July 17, 2009 |
| Last Updated: | August 31, 2011 |
| Health Authority: | Unspecified |
|
metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder recurrent bladder cancer stage IV bladder cancer urethral cancer associated with invasive bladder cancer |
anterior urethral cancer posterior urethral cancer recurrent urethral cancer recurrent prostate cancer stage IV prostate cancer |
|
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Prostatic Neoplasms Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases Urethral Diseases Kidney Diseases Ureteral Diseases Gemcitabine Bevacizumab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic |