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A Phase III Randomized Trial of Either M-VAC or Paclitaxel + Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High-Risk for Relapse


Phase 3
N/A
N/A
Not Enrolling
Both
Bladder Cancer, Urethral Cancer

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Trial Information

A Phase III Randomized Trial of Either M-VAC or Paclitaxel + Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High-Risk for Relapse


OBJECTIVES: I. Compare the recurrence rates and overall survival of patients treated with
postoperative adjuvant methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) to those
treated with combination paclitaxel and carboplatin for muscle invasive bladder cancer at
particularly high risk of relapse. II. Compare the relative toxicities of postoperative
M-VAC versus those encountered with postoperative paclitaxel and carboplatin. III. Compare
the quality of life scores during and following completion of treatment of patients in these
two treatment arms.

OUTLINE: This is a randomized study. Patients are stratified by N stage (N0 vs N+) and
performance status (0-1 vs 2). Patients are randomized to receive methotrexate, vinblastine,
doxorubicin, and cisplatin (arm I) or paclitaxel and carboplatin (arm II). Arm I: Patients
receive methotrexate IV push on days 1, 15, and 22; vinblastine IV push on days 2, 15, and
22; doxorubicin IV push on day 2; and cisplatin IV over 2 hours on day 2. Treatment repeats
every 28 days for 4 courses. Arm II: Patients receive paclitaxel IV over 3 hours on days 1
followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4
courses. Quality of life assessments are completed pretreatment, prior to course 3, 6 weeks
after the last dose of chemotherapy, and at 6, 12, and 24 months from the end of therapy.
Patients are followed every 3 months until year 2, every 6 months for years 2-5, and then
annually thereafter.

PROJECTED ACCRUAL: There will be 490 patients accrued into this study within 2.6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the
bladder or mixed histologies containing a component of transitional cell carcinoma Must
have undergone radical cystectomy and pelvic lymph node dissection within 12 weeks prior
to randomization No evidence of distant metastatic disease on pre- or postoperative
radiographic scans No positive surgical margins in the cystectomy specimen and no known
macroscopic residual disease left at time of cystectomy No bladder sparing surgery May
have undergone continent urinary diversion or neobladder procedure but must have recovered
completely from the effects of surgery Must have muscle-invasive disease on final
pathologic staging and have a primary tumor stage of pT4, any N, M0, or any pT, N+, M0, or
pT3b, any N, any M, and following a pelvic lymph node dissection have a pathologic nodal
stage of pN0 (only if pT3b or pT4), pN1, or pN2 Clinically unsuspected organ confined
prostate cancer found during cystoprostatectomy allowed

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
than 2 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at
least 60 mL/min Cardiovascular: No second degree atrioventricular block or bundle branch
block Other: No history of prior malignancy in the past 5 years except basal or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix No active infection
requiring antibiotics No history of allergic reaction to drugs utilizing the vehicle
Cremophor Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Recovered from all prior therapies Biologic therapy: No prior
biologic response modifier therapy No filgrastim (G-CSF) 24 hours pre- or
post-chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior radiotherapy as a component of bladder
sparing therapy No prior adjuvant radiotherapy for locally advanced disease with positive
margins Surgery: See Disease Characteristics Other: Prior intravesical therapy for
superficial bladder cancer allowed and recovered

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Bruce J. Roth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066808

NCT ID:

NCT00003701

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Urethral Cancer
  • stage III bladder cancer
  • transitional cell carcinoma of the bladder
  • urethral cancer associated with invasive bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms

Name

Location

Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
South Jersey Hospital - MillvilleMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Veterans Affairs Medical Center - New YorkNew York, New York  10010
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Hackensack University Medical CenterHackensack, New Jersey  07601
Riverview Medical CenterRed Bank, New Jersey  07701
Overlook HospitalSummit, New Jersey  07902-0220
Indiana University HospitalsIndianapolis, Indiana  46202