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A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

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 CenterNew York, New York  10021