Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCCTG-N0124 CALGB-30201, N0124, NCT00052949

Objectives

1. Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.
2. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.
3. 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).

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 3 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 2 weeks since prior radiotherapy
• No concurrent radiotherapy (including palliative therapy for bone pain)
  • Concurrent whole-brain radiotherapy for CNS progression allowed

Surgery

• More than 3 weeks since prior major surgery

Other

• No prior imatinib mesylate

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN)

  OR

• Direct bilirubin no greater than ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• 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

Other

• 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

Expected Enrollment

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.

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.]

Dy GK, Miller AA, Mandrekar S, et al.: A phase II NCCTG/CALGB trial of imatinib (STI571) in patients (pts) with c-kit-expressing relapsed small cell lung cancer (SCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7048, 632s, 2005.

Dy GK, Miller AA, Mandrekar SJ, et al.: A phase II trial of imatinib (ST1571) in patients with c-kit expressing relapsed small-cell lung cancer: a CALGB and NCCTG study. Ann Oncol 16 (11): 1811-6, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Alex Adjei, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 507-284-2511 Email: adjei.alex@mayo.edu

Cancer and Leukemia Group B

Antonius Miller, MD, Protocol chair		Ph: 336-713-4392; 800-446-2255

Registry Information
Official Title		Phase II Trial Of STI571 In Patients With Relapsed Small Cell Lung Cancer
Trial Start Date		2003-05-02
Registered in ClinicalTrials.gov		NCT00052949
Date Submitted to PDQ		2002-09-27
Information Last Verified		2004-08-19
NCI Grant/Contract Number		CA25224

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