Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer

Recurrent Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052949
• Other study ID #: NCI-2012-01801
• Secondary ID: NCI-2012-01801CD
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2003
• Last updated: October 7, 2013
• Start date: May 2003

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Recurrent Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• imatinib mesylate
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	North Central Cancer Treatment Group	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Cancer and Leukemia Group B

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients progression-free	Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.	16 weeks	No
Secondary	Survival time	Estimated using the method of Kaplan-Meier.	From registration to death due to any cause, assessed up to 3 years	No
Secondary	Time to disease progression	Estimated using the method of Kaplan-Meier.	From randomization to documentation of disease progression, assessed up to 3 years	No
Secondary	Duration of response (complete response [CR] or partial response [PR])		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	No
Secondary	Time to treatment failure		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	No
Secondary	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	The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.	Up to 3 years	Yes