Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052949

Purpose

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: imatinib mesylate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial Of STI571 In Patients With Relapsed Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

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

Study Start Date:

May 2003

Detailed Description:

OBJECTIVES:

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

Eligibility

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

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052949

Show 101 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Study Chair:	Alex A. Adjei, MD, PhD	Mayo Clinic
Study Chair:	Antonius A. Miller, MD	Wake Forest University

More Information

Additional Information:

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

Publications:

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, Aubry MC, Langdon RM Jr, Morton RF, Schild SE, Jett JR, Adjei AA. 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. 2005 Nov;16(11):1811-6. Epub 2005 Aug 8.

Study ID Numbers:	CDR0000269156, NCCTG-N0124, CALGB-30201
Study First Received:	January 24, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00052949 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors

Imatinib
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009