Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045604

Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining imatinib mesylate with irinotecan and cisplatin in treating patients who have extensive-stage small cell lung cancer

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: imatinib mesylate Drug: irinotecan hydrochloride	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of Imatinib (Gleevec) in Combination With Irinotecan and Cisplatin in Extensive Stage Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045604

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Lee M. Krug, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000256923, MSKCC-02015, NCI-5653
Study First Received:	September 6, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00045604
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Irinotecan
Camptothecin
Carcinoma
Neuroendocrine Tumors
Imatinib
Carcinoma, Small Cell
Neuroectodermal Tumors

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009