Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy


Phase 2/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

Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy


OBJECTIVES:

- Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate,
carboplatin, and vinblastine in patients with transitional cell cancer of the
urothelium who are ineligible for cisplatin-based chemotherapy.

- Compare the toxicity and acute and intermediate (1-2 years) side effects of these
regimens in these patients.

- Compare the complete response rates, progression-free survival, and overall survival of
patients treated with these regimens.

- Compare the symptoms and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive methotrexate* IV and vinblastine IV on days 1, 15, and 22 and
carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin
IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.

NOTE: * Methotrexate is omitted for patients with pleural effusion or ascites until complete
resolution and for patients with a glomerular filtration rate less than 30 mL/min or
creatinine greater than 2 mg/dL

Patients in either arm who achieve a complete response (CR) receive 2 additional courses of
chemotherapy beyond CR.

Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6
weeks of completion of therapy.

Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months
thereafter.

PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the
phase II portion of this study. A total of 225 patients will be accrued for the phase II +
III portions of this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed transitional cell cancer of the urothelium, including the
renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following
criteria:

- Unresected positive lymph node

- Distant metastases (M1, stage IV)

- Unresectable primary bladder cancer (T3-4)

- Measurable disease

- Ineligible for cisplatin-based chemotherapy and presenting with the following:

- WHO performance status 2 AND/OR

- Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min

- No brain metastases or other CNS lesions

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- See Disease Characteristics

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 125,000/mm^3

Hepatic:

- Bilirubin no greater than 1.25 times normal

- AST/ALT no greater than 3 times normal (5 times normal if liver metastases are
present)

Renal:

- See Disease Characteristics

- Calcium normal

Other:

- Not pregnant or nursing

- 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 participation

- No other prior or concurrent malignancy except cured basal cell skin cancer or
carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior systemic biologic therapy

Chemotherapy:

- See Disease Characteristics

- No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 months since prior radiotherapy

- Prior radiotherapy to study lesions allowed if there is evidence of disease
progression

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Duration of survival

Safety Issue:

No

Principal Investigator

Gerwin Kaiser, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinikum Nuernberg - Klinikum Nord

Authority:

United States: Federal Government

Study ID:

EORTC-30986

NCT ID:

NCT00014274

Start Date:

January 2001

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

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