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Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00248482
Enrollment
6
Registered
2005-11-04
Start date
2002-02-28
Completion date
2008-01-31
Last updated
2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer, recurrent small cell lung cancer

Brief summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back. PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the tolerability of imatinib mesylate maintenance therapy in these patients. * Determine the response rate in patients treated with irinotecan and cisplatin. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy. * Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year. After completion of study treatment, patients are followed for 4 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Interventions

DRUGCisplatin

Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles

DRUGGleevec™

Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.

DRUGirinotecan

Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Novartis Pharmaceuticals
CollaboratorINDUSTRY
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Extensive stage disease, defined by 1 of the following criteria: * Disease extends beyond one hemithorax and regional lymph nodes * Cytologically positive pleural effusion * Meets 1 of the following criteria: * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy * Evaluable disease * No history of untreated or symptomatic brain or leptomeningeal metastases * Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy PATIENT CHARACTERISTICS: Performance status * SWOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal * Creatinine normal OR * Creatinine clearance ≥ 65 mL/min Cardiovascular * No uncontrolled congestive heart failure * No uncontrolled angina * No myocardial infarction and/or stroke within the past 3 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No peripheral neuropathy ≥ grade 2 * No symptomatic edema from any etiology * No known HIV positivity * No other serious medical illness * No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy for SCLC Endocrine therapy * No concurrent routine systemic corticosteroids Radiotherapy * See Disease Characteristics * At least 2 weeks since prior palliative radiotherapy Surgery * More than 2 weeks since prior major surgery Other * No concurrent therapeutic anticoagulation with warfarin * Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry * No other concurrent participation in another study of an investigational agent

Design outcomes

Primary

MeasureTime frame
Progression-free survivalat 4 months

Secondary

MeasureTime frame
Overall survivalat least 4 months after discontinuation of treatment
Tolerability of Gleevec maintenance therapy30 days after completion of study treatment
Response rate as measured by RECIST atBaseline and every 8 weeks during study treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026