Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052949
First received: January 24, 2003
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Recurrent Small Cell Lung Cancer
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The proportion of patients progression-free [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.


Secondary Outcome Measures:
  • Survival time [ Time Frame: From registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan-Meier.

  • Time to disease progression [ Time Frame: From randomization to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan-Meier.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.


Estimated Enrollment: 91
Study Start Date: May 2003
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Alex Adjei North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052949     History of Changes
Other Study ID Numbers: NCI-2012-01801, NCI-2012-01801, CDR0000269156, NCCTG-N0124, CALGB-30201, N0124, N0124, U10CA025224
Study First Received: January 24, 2003
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014