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Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer



- 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.


- 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


- 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


Performance status

- SWOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8 g/dL


- 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)


- Creatinine normal OR

- Creatinine clearance ≥ 65 mL/min


- No uncontrolled congestive heart failure

- No uncontrolled angina

- No myocardial infarction and/or stroke within the past 3 months


- 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



- No prior chemotherapy for SCLC

Endocrine therapy

- No concurrent routine systemic corticosteroids


- See Disease Characteristics

- At least 2 weeks since prior palliative radiotherapy


- More than 2 weeks since prior major surgery


- 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:


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:


Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




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



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201