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Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium


OBJECTIVES: I. Compare the objective response rate, duration of remission, overall survival,
and quality of life of patients with progressing regional or metastatic transitional cell
carcinoma (or mixed histologies with a component of transitional cell carcinoma) of the
urothelium treated with methotrexate, vinblastine, doxorubicin, and cisplatin vs carboplatin
and paclitaxel. II. Compare the relative toxic effects of these treatment regimens in this
patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms. Arm I: Patients receive methotrexate IV on days 1, 15, and 22; vinblastine
IV on days 2, 15, and 22; and cisplatin IV over 2 hours and doxorubicin IV on day 2.
Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable
toxicity or disease progression. Arm II: Patients receive paclitaxel IV over 3 hours
immediately followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for
a total of 6 courses in the absence of unacceptable toxicity or disease progression. Quality
of life is assessed before treatment, before courses 2 and 4, at 4 weeks after last course,
and at 10 months. Patients are followed every 3 months for 1 year and then every 6 months
until disease progression.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study within 3.3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the
urothelium (renal pelvis, ureter, bladder, or urethra) or mixed histologies containing a
component of transitional cell carcinoma of the urothelium with manifestations of
progressing regional or metastatic cancer Clinically unsuspected organ-confined prostate
cancer found during cystoprostatectomy allowed Evaluable or measurable disease No
significant pericardial or pleural effusion or edema No significant ascites No CNS
metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: AST no greater than 2 times upper limit of normal Bilirubin no
greater than 1.5 mg/dL Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No
history of severe cardiovascular disease (American Heart Association class III or IV),
uncontrolled congestive heart failure, or cardiac dysrhythmias Other: Prior malignancy
allowed if curatively treated with no evidence of recurrence No active infection requiring
parenteral antibiotics Not pregnant or nursing Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier
therapy No concurrent filgrastim (G-CSF) within 24 hours prior to and after study
chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior pelvic radiotherapy as a component of
bladder-sparing therapy or as an adjuvant for locally advanced disease with positive
margins No concurrent local radiotherapy for pain control or life-threatening situations
Surgery: See Disease Characteristics

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: Food and Drug Administration

Study ID:

CDR0000066368

NCT ID:

NCT00003376

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • anterior urethral cancer
  • posterior urethral cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201