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Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer

Inclusion Criteria:

1. Histologically or cytologically confirmed extensive-stage SCLC, which is
c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that
extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral
hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive
pleural effusion.

2. No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and
irinotecan, at the dosages mentioned in the protocol, prior to registration can be
registered on the trial if done so within 21 days after the start of the first cycle
of chemotherapy. Prior palliative radiation therapy will be allowed as long as
radiation was completed at least 2 weeks before starting protocol therapy.

3. At least 18 years of age

4. At least one uni-dimensionally measurable lesion or an evaluable outside the field of
any prior radiation therapy.

5. Adequate organ function

6. Patients must sign informed consent that details the investigational nature of the
study according to the institutional and federal guidelines.

Exclusion Criteria:

1. Symptomatic or history of untreated brain or leptomeningeal metastases. Treated
patients should be neurologically stable for 2 weeks after completion of appropriate

2. Previous or concurrent malignancies, with the exception of adequately treated
squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix,
or any other malignancy treated and in clinical remission for more than 3 years.

3. Major surgery or radiation therapy within 2 weeks of enrollment.

4. Peripheral neuropathy of NCI grade greater than 2.

5. Symptomatic edema from any etiology.

6. Therapeutic anticoagulation with warfarin. Patients can be eligible if they are
changed from warfarin to low molecular weight heparin or heparin at least 2 weeks
prior to starting Gleevec.

7. Serious concomitant medical illness, including, but not limited to, uncontrolled
congestive cardiac failure, uncontrolled angina, myocardial infarction and/or stroke
within 3 months, or HIV infection.

8. Acute or chronic liver disease (e.g., chronic active hepatitis, cirrhosis).

9. History of dementia, active psychiatric disorder or any other condition, considered
by the treating physician to impair the patient's ability to take oral pills on a
daily basis or comply with the protocol requirements.

10. Pregnant or lactating females. All pre-menopausal and peri-menopausal women should
have a negative urine pregnancy test prior to enrollment. All patients, men and
women, of reproductive potential should agree to use an effective contraceptive
method for the duration of the trial and for 3 months after discontinuation of study

11. Patients should not participate in other investigational agent study while taking
part in this trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.

Principal Investigator

Gregory Kalemkerian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2001-066



Start Date:

March 2002

Completion Date:

April 2006

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Univeristy of Michigan Cancer Center Ann Arbor, Michigan  48109