Clinical trial NCT00052949: Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
Official title: Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Small Cell Lung Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Cancer and Leukemia Group B
First posted: 2003-01-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The proportion of patients progression-free
timeFrame: 16 weeks
Secondary outcomes:
measure: Survival time
timeFrame: From registration to death due to any cause, assessed up to 3 years
measure: Time to disease progression
timeFrame: From randomization to documentation of disease progression, assessed up to 3 years
measure: Duration of response (complete response [CR] or partial response [PR])
timeFrame: 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
measure: Time to treatment failure
timeFrame: 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
measure: 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
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: North Central Cancer Treatment Group
state: Minnesota
Study officials:
affiliation: North Central Cancer Treatment Group
name: Alex Adjei
role: PRINCIPAL_INVESTIGATOR
References: