Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Small Cell Lung Cancer	Drug: imatinib mesylate; Other: laboratory biomarker analysis	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	91 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Study Start Date :	May 2003
Actual Primary Completion Date :	October 2007

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Treatment (imatinib mesylate); Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.	Drug: imatinib mesylate; Given orally Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

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Primary Outcome Measures :

1. The proportion of patients progression-free [ Time Frame: 16 weeks ]
   Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Secondary Outcome Measures :

1. Survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]
   Estimated using the method of Kaplan-Meier.
2. Time to disease progression [ Time Frame: From randomization to documentation of disease progression, assessed up to 3 years ]
   Estimated using the method of Kaplan-Meier.
3. Duration of response (complete response [CR] or partial response [PR]) [ Time Frame: The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years ]
4. Time to treatment failure [ Time Frame: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years ]
5. Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 3 years ]
   The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Principal Investigator:	Alex Adjei	North Central Cancer Treatment Group

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052949 History of Changes
Other Study ID Numbers:	NCI-2012-01801; NCI-2012-01801 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000269156; NCCTG-N0124; CALGB-30201; N0124 ( Other Identifier: North Central Cancer Treatment Group ); N0124 ( Other Identifier: CTEP ); U10CA025224 ( U.S. NIH Grant/Contract )
First Posted:	January 27, 2003
Last Update Posted:	October 8, 2013
Last Verified:	October 2013

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases	Carcinoma, Bronchogenic; Bronchial Neoplasms; Imatinib Mesylate; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action