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Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022191
Enrollment
608
Registered
2003-01-27
Start date
2001-05-31
Completion date
Unknown
Last updated
2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Keywords

stage IV bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter

Brief summary

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 which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

Detailed description

OBJECTIVES: * Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel. * Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.

Interventions

DRUGcisplatin
DRUGgemcitabine hydrochloride
DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Groupe D'Etude des Tumeurs Uro-Genitales
CollaboratorOTHER
Institute of Cancer Research, United Kingdom
CollaboratorOTHER
Central European Cooperative Oncology Group
CollaboratorOTHER
NCIC Clinical Trials Group
CollaboratorNETWORK
SWOG Cancer Research Network
CollaboratorNETWORK
German Association of Urologic Oncology
CollaboratorOTHER
Spanish Oncology Genito-Urinary Group
CollaboratorOTHER
Medical Research Council
CollaboratorOTHER_GOV
European Organisation for Research and Treatment of Cancer - EORTC
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis * T4b, any N OR any T, N2-3 OR M1 * Ineligible for surgery or radiotherapy with curative intent * Measurable or evaluable disease * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.25 times normal * AST or ALT less than 2.5 times normal Renal: * Glomerular filtration rate at least 60 mL/min * Calcium normal or clinically insignificant Cardiovascular: * No clinically significant cardiac arrhythmia * No congestive heart failure * No complete bundle branch block * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No psychological, familial, sociological, or geographical condition that would preclude study compliance * No grade 3 or 4 infection without neutropenia * No other serious concurrent systemic disorder that would preclude study therapy * No mental disorder that would preclude study compliance * No grade II or greater neuropathy * No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL) PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy) * At least 4 weeks since prior immunotherapy Chemotherapy: * No prior systemic chemotherapy * At least 4 weeks since prior local intravesical chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No more than 1 prior course of radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Slovakia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026