Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.

II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.

III. Correlate individual patient variation in clinical (toxicity and/or activity), pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to this drug with genetic differences in proteins involved in drug response (transport, metabolism, and/or mechanism of action).

OUTLINE: This is a multicenter study. Patients are stratified according to length of prior therapy (less than 3 months vs at least 3 months).

Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.

\*Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.

NOTE: \*Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy.

PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (imatinib mesylate)

Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

imatinib mesylate

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

imatinib mesylate

Given orally

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically confirmed small cell lung cancer (SCLC)

* No mixed histology
* Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
* c-Kit positive by immunohistochemistry (at least 1+)
* At least 1 unidimensionally measurable lesion

* Longest diameter at least 20 mm
* No uncontrolled CNS metastasis

* Treated CNS metastasis allowed
* Performance status - ECOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
* Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Direct bilirubin no greater than ULN
* Creatinine no greater than 1.5 times ULN
* No unstable angina pectoris
* No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
* No myocardial infarction within the past 3 months
* No uncontrolled infection
* No other malignancy within the past 3 years except skin cancer or localized prostate cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* See Disease Characteristics
* More than 3 weeks since prior chemotherapy
* More than 2 weeks since prior radiotherapy
* No concurrent radiotherapy(including palliative therapy for bone pain)

* Concurrent whole-brain radiotherapy for CNS progression allowed
* More than 3 weeks since prior major surgery
* No prior imatinib mesylate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alex Adjei

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Central Cancer Treatment Group

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States