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

NCT00248482 | Completed Phase 2 DMC

• 5 other identifiers: CDR0000445222P30CA022453WSU-C-2461WSU-UMCC-2001-066CST1571B US93
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  at 4 months

Secondary Outcomes (3)

• Overall survival

  at least 4 months after discontinuation of treatment

• Tolerability of Gleevec maintenance therapy

  30 days after completion of study treatment

• Response rate as measured by RECIST at

  Baseline and every 8 weeks during study treatment

Study Arms (1)

Irinotecan, Cisplatin & Gleevec™

EXPERIMENTAL

Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles

Drug: Cisplatin; Drug: Gleevec™; Drug: irinotecan

Interventions

Cisplatin DRUG

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

Also known as: Platinol ®, Platinol®-AQ, CDDP

Irinotecan, Cisplatin & Gleevec™

Gleevec™ DRUG

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

Also known as: STI-571, imatinib mesylate

Irinotecan, Cisplatin & Gleevec™

irinotecan DRUG

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

Also known as: Camptosar®, Camptothecin-11, CPT-11

Irinotecan, Cisplatin & Gleevec™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Cisplatin; Imatinib Mesylate; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Camptothecin; Alkaloids

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: February 1, 2002
• Primary Completion: April 1, 2005
• Study Completion: January 1, 2008
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (2)