A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
N/A
N/A
Both
Lung Cancer
Trial Information
A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate when administered with
cisplatin and irinotecan in patients with extensive stage small cell lung cancer.
- Determine the recommended phase II dose of imatinib mesylate in patients treated with
this regimen.
- Determine the response rate, median duration of response, progression-free survival,
median survival, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate.
Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 60 minutes on days
1, 8, and 15. Treatment repeats every 28 days for a maximum of 4 courses. Patients also
receive oral imatinib mesylate daily continually for one week prior to, during, and after
chemotherapy in the absence of 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 at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at the recommended phase II dose (one dose level below the MTD).
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1-2
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed extensive stage small cell lung cancer
- Incurable but amenable to treatment with chemotherapy
- c-kit positive by immunohistochemistry of original biopsy or other metastatic
site
- At least one unidimensionally measurable lesion
- > 20 mm by conventional techniques or > 10 mm by spiral CT scan
- No prior radiotherapy to target measurable lesion(s), unless there is documented
disease progression
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- ECOG 0-1 OR
- Karnofsky 70-100%
Life expectancy
- More than 6 weeks
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
- AST and/or ALT ≤ 2.5 times upper limit of normal
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Gastrointestinal
- No concurrent untreated upper gastrointestinal bleeding that has not been fully
investigated
- No gastrointestinal disease that would impair drug absorption
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception prior to, during, and for 3
months after study participation
- No history of ototoxicity
- No history of peripheral neuropathy
- No traumatic injury within the past 21 days
- No ongoing or active infection
- No other concurrent significant medical condition that would preclude study
participation
- No concurrent psychiatric condition or social situation that would preclude study
compliance
- No other malignancy within the past 5 years except treated nonmelanoma skin cancer,
carcinoma in situ, or stage A prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of marrow
Surgery
- More than 3 weeks since prior major surgery
- No prior surgical procedure impairing absorption
Other
- No prior c-kit-targeted therapy
- No concurrent therapeutic dose of warfarin
- Mini-dose warfarin for prophylaxis and low-molecular weight heparin allowed
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No concurrent amifostine
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mark D. Vincent, MD
Investigator Role:
Study Chair
Investigator Affiliation:
London Regional Cancer Program at London Health Sciences Centre
Authority:
United States: Federal Government
Study ID:
CDR0000258487
NCT ID:
NCT00052494
Start Date:
April 2003
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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