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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CCF-6695 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | |||
| irinotecan hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response | ||
| Safety and efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy > 3 months
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 9.5 g/dL
Creatinine ≤ 1.8 mg/dL
Bilirubin < 1.5 mg/dL
Calcium < 11.5 mg/dL
ALT and AST < 3 times upper limit of normal
No history of any of the following:
No other prior malignancy except for the following:
No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
No local or systemic infections requiring IV antibiotics within the past 28 days
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M. Bukowski, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |