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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-C-2461 | Other Identifier | Barbara Ann Karmanos Cancer Institute | |
| WSU-UMCC-2001-066 | |||
| CST1571B US93 | Other Identifier | Novartis Pharmaceuticals |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Novartis Pharmaceuticals | INDUSTRY |
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RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, 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. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed for 4 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan, Cisplatin & Gleevec™ | Experimental | Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | at least 4 months after discontinuation of treatment | |
| Tolerability of Gleevec maintenance therapy | 30 days after completion of study treatment | |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
Extensive stage disease, defined by 1 of the following criteria:
Meets 1 of the following criteria:
No history of untreated or symptomatic brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Meets 1 of the following criteria:
No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation with warfarin
No other concurrent participation in another study of an investigational agent
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| Name | Affiliation | Role |
|---|---|---|
| Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States | ||
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068877 | Imatinib Mesylate |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Gleevec™ | Drug | Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease. |
|
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| irinotecan | Drug | Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles |
|
|
| Response rate as measured by RECIST at |
| Baseline and every 8 weeks during study treatment |
| Barbara Ann Karmanos Cancer Institute |
| Detroit |
| Michigan |
| 48201-1379 |
| United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001549 |
| Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D002166 | Camptothecin |
| D000470 | Alkaloids |