|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066612 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2003 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra
The following additional histologic subtypes are eligible:
The following histologic subtypes are ineligible:
Measurable disease
No uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000316428, SWOG-S0306 |
| Study First Received: | August 6, 2003 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066612 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Urinary Tract Neoplasm Kidney Cancer Cystocele Irinotecan Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Camptothecin Recurrence |
Carcinoma Renal Cancer Urologic Diseases Kidney Neoplasms Urethral Cancer Urethral Neoplasms Bladder Neoplasm Kidney Diseases Antineoplastic Agents, Phytogenic Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Urethral Diseases Kidney Diseases |
Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Camptothecin Pharmacologic Actions Carcinoma Neoplasms Urethral Neoplasms Ureteral Neoplasms Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |