Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer |
- Response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Tolerance [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Median and progression-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2001 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 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 of the bladder
- Locally advanced or metastatic disease
Unidimensionally measurable disease by physical exam or imaging study
The following are not considered measurable disease:
- Bone only disease
- Pleural or peritoneal effusions
- CNS lesions
- Irradiated lesions unless disease progression was documented after radiotherapy
- Not amenable to surgery
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine ≤ 2.0 mg/dL
Gastrointestinal
- No active inflammatory bowel disease
- No significant bowel obstruction
- No chronic diarrhea
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy except nonmelanoma skin cancer
- No mental incapacitation or psychiatric illness that would preclude giving informed consent
- No other severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No more than 1 prior platinum-based chemotherapy regimen
- At least 4 weeks since prior chemotherapy
- No prior irinotecan or gemcitabine
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent palliative radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another clinical trial
Contacts and Locations| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Study Chair: | Uzair B. Chaudhary, MD | Medical University of South Carolina |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00089128 History of Changes |
| Other Study ID Numbers: | CDR0000378047, MUSC-100615, PHARMACIA-440EONCO020298, MUSC-HR-10212 |
| Study First Received: | August 4, 2004 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Medical University of South Carolina:
|
transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer stage IV bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Irinotecan Camptothecin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013