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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00066612

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Drug: irinotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

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.
Determine the qualitative and quantitative toxic effects of this drug in these patients.
Determine the overall and progression-free survival of patients treated with this drug.

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Irinotecan	Drug: irinotecan hydrochloride Irinotecan will be given 250 mg/m^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs

Arm

Intervention/Treatment

Experimental: Treatment

Irinotecan

Drug: irinotecan hydrochloride

Irinotecan will be given 250 mg/m^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs

Outcome Measures

Primary Outcome Measures

Probability of response (confirmed complete and partial response) [From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years]

Secondary Outcome Measures

Number and grade of adverse events [From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years]
Overall survival [From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years]
Progression-free survival [From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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