Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the 4-month progression-free survival rate in patients with c-kit positive,
extensive stage small cell lung cancer treated with maintenance therapy comprising
imatinib mesylate after induction therapy comprising irinotecan and cisplatin.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
- Determine the response rate in patients treated with irinotecan and cisplatin.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and
cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving a response (partial or
complete) or stable disease proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months
in the absence of disease progression or unacceptable toxicity. Some patients may
continue to receive therapy for up to 1 year.
After completion of study treatment, patients are followed for 4 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Extensive stage disease, defined by 1 of the following criteria:
- Disease extends beyond one hemithorax and regional lymph nodes
- Cytologically positive pleural effusion
- Meets 1 of the following criteria:
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside
the field of any prior radiotherapy
- Evaluable disease
- No history of untreated or symptomatic brain or leptomeningeal metastases
- Prior brain metastases allowed provided patient is neurologically stable for 2
weeks after completion of therapy
PATIENT CHARACTERISTICS:
Performance status
- SWOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 65 mL/min
Cardiovascular
- No uncontrolled congestive heart failure
- No uncontrolled angina
- No myocardial infarction and/or stroke within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No symptomatic edema from any etiology
- No known HIV positivity
- No other serious medical illness
- No other malignancy within the past 3 years except adequately treated squamous cell
or basal cell skin cancer or carcinoma in situ of the cervix
- No history of dementia, active psychiatric disorder, or other condition that would
preclude study compliance or ability to take oral medication on a daily basis
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy for SCLC
Endocrine therapy
- No concurrent routine systemic corticosteroids
Radiotherapy
- See Disease Characteristics
- At least 2 weeks since prior palliative radiotherapy
Surgery
- More than 2 weeks since prior major surgery
Other
- No concurrent therapeutic anticoagulation with warfarin
- Concurrent low molecular weight heparin allowed provided regimen was initiated ≥
2 weeks prior to study entry
- No other concurrent participation in another study of an investigational agent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
at 4 months
Safety Issue:
No
Principal Investigator
Shirish M. Gadgeel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000445222
NCT ID:
NCT00248482
Start Date:
February 2002
Completion Date:
January 2008
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
