NCT00022191CompletedPhase 3
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
European Organisation for Research and Treatment of Cancer - EORTC234 sites in 1 country608 target enrollmentStarted: May 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 608
- Locations
- 234
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •18 and over
- •Performance status:
- •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
- •Bilirubin less than 1.25 times normal
- •AST or ALT less than 2.5 times normal
- •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
- •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
- •See Disease Characteristics
- •Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)
Exclusion Criteria
- Not provided
Investigators
Study Sites (234)
Loading locations...
Similar Trials
Withdrawn
Phase 3
S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent, Persistent, or Metastatic Cervical CancerCervical CancerNCT00057928SWOG Cancer Research Network
Unknown
Phase 3
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung CancerLung CancerNCT00039039IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy300
Unknown
Phase 3
Chemotherapy in Treating Patients With Cancer of Unknown Primary OriginCarcinoma of Unknown PrimaryNCT00003558Academisch Ziekenhuis Maastricht140
Completed
Phase 2
Paclitaxel With or Without PSC 833 in Treating Patients With Metastatic Breast CancerBreast CancerNCT00002937City of Hope Medical Center70
Completed
Phase 3
Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast CancerBreast CancerNCT00028990Eastern Cooperative Oncology Group722