A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate when administered with
irinotecan and cisplatin in patients with extensive stage small cell lung cancer.
- Determine the effect of imatinib mesylate on irinotecan metabolism by the cytochrome
p450 system in these patients.
- Determine the response rate, time to progression, and survival of patients treated with
this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive irinotecan IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60
minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients also receive oral imatinib mesylate once or
twice daily beginning on day 22 of course 1 and continuing until disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-18
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed small cell lung cancer
- Extensive stage disease
- Measurable or evaluable indicator lesion
- No symptomatic or uncontrolled brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 4,000/mm3
- Platelet count at least 160,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1 mg/dL
- AST no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN
Renal
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after study
- No other active cancer except previously treated carcinoma in situ, non -melanoma
skin cancer, or stage I prostate cancer
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study
- No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy except for non-cancer conditions (e.g., low-dose methotrexate
for rheumatoid arthritis)
Endocrine therapy
- Not specified
Radiotherapy
- At least 2 weeks since prior radiotherapy to major bone marrow-containing areas
Surgery
- Not specified
Other
- No concurrent warfarin for therapeutic anticoagulation
- Low-molecular weight heparin or heparin allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lee M. Krug, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000256923
NCT ID:
NCT00045604
Start Date:
July 2002
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
