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

This study has been completed.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00248482
First received: November 3, 2005
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Cisplatin
Drug: Gleevec™
Drug: irinotecan
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 Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: at 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: at least 4 months after discontinuation of treatment ] [ Designated as safety issue: No ]
  • Tolerability of Gleevec maintenance therapy [ Time Frame: 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Response rate as measured by RECIST at [ Time Frame: Baseline and every 8 weeks during study treatment ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2002
Study Completion Date: January 2008
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan, Cisplatin & Gleevec™

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
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Other Names:
  • Platinol ®
  • Platinol®-AQ
  • CDDP
Drug: Gleevec™
Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
Other Names:
  • STI-571
  • imatinib mesylate
Drug: irinotecan
Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
Other Names:
  • Camptosar®
  • Camptothecin-11
  • CPT-11

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00248482

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Novartis Pharmaceuticals
Investigators
Principal Investigator: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00248482     History of Changes
Other Study ID Numbers: CDR0000445222, P30CA022453, WSU-C-2461, WSU-UMCC-2001-066, CST1571B US93
Study First Received: November 3, 2005
Last Updated: April 25, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
extensive stage small cell lung cancer
recurrent small cell lung cancer

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

ClinicalTrials.gov processed this record on October 01, 2014