Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0306 S0306, NCT00066612

Objectives

1. Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.
2. Determine the qualitative and quantitative toxic effects of this drug in these patients.
3. Determine the overall and progression-free survival of patients treated with this drug.

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

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 myelosuppressants
• No concurrent medications that cause diarrhea
• Concurrent gabapentin or other non-EIACDs 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/mm³
• Platelet count at least 100,000/mm³

Hepatic

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

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 5-10 months.

Outcomes

Objective response rate as measured by RECIST criteria every 6-9 weeks

Safety as measured by CTC every 3 weeks

Outline

This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Beer TM, Goldman B, Nichols CR, et al.: Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy. Clin Genitourin Cancer 6 (1): 36-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Tomasz Beer, MD, Study coordinator		Ph: 503-494-0365
Craig Nichols, MD, Study coordinator		Ph: 503-494-6346; 800-494-1234

Registry Information
Official Title		Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium
Trial Start Date		2003-07-15
Registered in ClinicalTrials.gov		NCT00066612
Date Submitted to PDQ		2003-06-23
Information Last Verified		2007-02-01
NCI Grant/Contract Number		CA32102

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