Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 120 |
| Updated: | 6/17/2018 |
| Start Date: | December 2002 |
| End Date: | May 14, 2018 |
A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to
damage tumor cells. It is not yet known which regimen of combination chemotherapy plus
radiation therapy with or without surgery is more effective in treating bladder cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy
regimens and radiation therapy with or without radical cystectomy in treating patients who
have stage II or stage III bladder cancer.
dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to
damage tumor cells. It is not yet known which regimen of combination chemotherapy plus
radiation therapy with or without surgery is more effective in treating bladder cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy
regimens and radiation therapy with or without radical cystectomy in treating patients who
have stage II or stage III bladder cancer.
OBJECTIVES:
- Estimate the safety and tolerability of induction paclitaxel, cisplatin, and
radiotherapy or fluorouracil, cisplatin, and radiotherapy followed by consolidation
chemoradiotherapy or radical cystectomy and adjuvant gemcitabine, paclitaxel, and
cisplatin in patients with operable stage II or III bladder cancer.
- Estimate the efficacy of these regimens, in terms of complete response, in patients who
have undergone prior transurethral resection (TUR).
- Estimate the efficacy of these regimens after TUR, in terms of preserving the native
tumor-free bladder 5 years after therapy, in these patients.
- Estimate the function of the preserved bladder in patients treated with these regimens
after TUR.
- Determine the value of tumor histopathologic, molecular genetic, and DNA content
parameters as possible prognostic factors for initial tumor response and recurrence-free
survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T
stage (T2 vs T3/T4 ). Patients are randomized to one of two treatment arms.
- Induction therapy (weeks 1-3):
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive pelvic
radiotherapy twice daily on days 1-5, 8-12, and 15-17.
- Arm II: Patients receive fluorouracil IV over 24 hours on days 1-3 and 15-17 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive pelvic
radiotherapy as in arm I.
Patients in both arms who achieve complete response after induction therapy proceed to
consolidation therapy on week 8. Patients with operable pT1 or worse tumor response proceed
to radical cystectomy on week 9.
- Consolidation therapy (weeks 8 and 9):
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV
over 1 hour on days 1, 2, 8, and 9. Patients also receive pelvic radiotherapy twice
daily on days 1-5 and 8-10.
- Arm II: Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin
as in arm I. Patients also receive radiotherapy as in arm I.
- Adjuvant chemotherapy (weeks 21-33 or 17-29): Beginning 12 weeks after consolidation
therapy or 8 weeks after radical cystectomy, patients receive gemcitabine IV over 30-60
minutes, paclitaxel IV over 1 hour, and cisplatin IV over 1 hour on days 1 and 8.
Treatment repeats every 3 weeks for 4 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this
study within 3 years.
- Estimate the safety and tolerability of induction paclitaxel, cisplatin, and
radiotherapy or fluorouracil, cisplatin, and radiotherapy followed by consolidation
chemoradiotherapy or radical cystectomy and adjuvant gemcitabine, paclitaxel, and
cisplatin in patients with operable stage II or III bladder cancer.
- Estimate the efficacy of these regimens, in terms of complete response, in patients who
have undergone prior transurethral resection (TUR).
- Estimate the efficacy of these regimens after TUR, in terms of preserving the native
tumor-free bladder 5 years after therapy, in these patients.
- Estimate the function of the preserved bladder in patients treated with these regimens
after TUR.
- Determine the value of tumor histopathologic, molecular genetic, and DNA content
parameters as possible prognostic factors for initial tumor response and recurrence-free
survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T
stage (T2 vs T3/T4 ). Patients are randomized to one of two treatment arms.
- Induction therapy (weeks 1-3):
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive pelvic
radiotherapy twice daily on days 1-5, 8-12, and 15-17.
- Arm II: Patients receive fluorouracil IV over 24 hours on days 1-3 and 15-17 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive pelvic
radiotherapy as in arm I.
Patients in both arms who achieve complete response after induction therapy proceed to
consolidation therapy on week 8. Patients with operable pT1 or worse tumor response proceed
to radical cystectomy on week 9.
- Consolidation therapy (weeks 8 and 9):
- Arm I: Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV
over 1 hour on days 1, 2, 8, and 9. Patients also receive pelvic radiotherapy twice
daily on days 1-5 and 8-10.
- Arm II: Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin
as in arm I. Patients also receive radiotherapy as in arm I.
- Adjuvant chemotherapy (weeks 21-33 or 17-29): Beginning 12 weeks after consolidation
therapy or 8 weeks after radical cystectomy, patients receive gemcitabine IV over 30-60
minutes, paclitaxel IV over 1 hour, and cisplatin IV over 1 hour on days 1 and 8.
Treatment repeats every 3 weeks for 4 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this
study within 3 years.
DISEASE CHARACTERISTICS:
- Histologically confirmed operable primary muscle invasive bladder cancer
- T2-T4a, NX or N0, M0 (stage II or III)
- Must have an adequate functioning bladder
- Must have undergone a prior transurethral resection of the bladder tumor within the
past 8 weeks
- No evidence of tumor-related hydronephrosis
- No evidence of distant metastases or histologically or cytologically confirmed lymph
node metastases
- Patients with involvement of the prostatic urethra with transitional cell cancer that
was visibly completely resected are allowed
- No evidence of stromal invasion of the prostate
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin at least 10 g/dL
- White blood cell (WBC) count at least 4,000/mm^3
- Absolute neutrophil count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Serum bilirubin no greater than 2.0 mg/dL
Renal
- Serum creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater
than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion
of the study chair
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a
prostate cancer, or carcinoma in situ of the cervix
- Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical
cystectomy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- See Disease Characteristics
Other
- No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g.,
aminoglycosides)
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