S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra

• Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease

• The following additional histologic subtypes are eligible:

• Poorly differentiated TCC

• Predominant TCC with rare foci of squamous differentiation

• Predominant TCC with rare foci of adenocarcinoma

• The following histologic subtypes are ineligible:

• Adenocarcinoma

• Small cell carcinoma

• Sarcoma

• Squamous cell carcinoma

• Mixed adeno/squamous/transitional histology

• Incurable by surgery or radiotherapy

• Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease

• Measurable disease

• Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease

• No uncontrolled central nervous system (CNS) metastases

• CNS metastases that have responded to or stabilized after prior radiotherapy are allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,200/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine less than 2 times ULN

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 28 days since prior chemotherapy

• No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• At least 28 days since prior radiotherapy to the pelvis

Surgery

• Not specified

Other

• Recovered from prior therapy

• Prior adjuvant therapy allowed

• At least 14 days since prior Hypericum perforatum (St. John's Wort)

• More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs)

• No St. John's Wort during and for 7 days after study participation

• No concurrent EIACDs

• No concurrent medications that cause myelosuppression

• No concurrent medications that cause diarrhea

• Concurrent gabapentin or other non-EIACDs are allowed