S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00066612
First received: August 6, 2003
Last updated: October 31, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Probability of response (confirmed complete and partial response) [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number and grade of adverse events [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | July 2003 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00066612 History of Changes |
| Other Study ID Numbers: | CDR0000316428, U10CA032102, S0306 |
| Study First Received: | August 6, 2003 |
| Last Updated: | October 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
recurrent bladder cancer stage IV bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
transitional cell carcinoma of the bladder anterior urethral cancer posterior urethral cancer recurrent urethral cancer urethral cancer associated with invasive bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urethral Diseases |
Kidney Diseases Ureteral Diseases Irinotecan Camptothecin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013