Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

Phase II Evaluation of Gleevec Combined With Camptosar Plus Paraplatin in Patients With Previously Untreated Extensive Stage SCLC

This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Imatinib; Drug: Irinotecan

Detailed Description

Upon determination of eligibility, all patients will be receive:

• Irinotecan + Carboplatin + Imatinib

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Small cell lung cancer with extensive stage disease confirmed by biopsy
• Measurable or evaluable disease
• Ability to perform activities of daily living with minimal assistance
• Adequate bone marrow, liver and kidney
• No active brain metastasis.
• No previous chemotherapy or radiation therapy
• Give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Limited stage disease (includes IA, IB, IIA, IIB, and IIIA)
• Active brain metastasis
• Age < 18 years old
• History of a prior malignancy within three years
• Women pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate
Response duration

Secondary Outcome Measures

Outcome Measure
Time to progression
Overall toxicity

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Novartis; Pharmacia and Upjohn

Publications and helpful links

General Publications

• Spigel DR, Hainsworth JD, Simons L, Meng C, Burris HA 3rd, Yardley DA, Grapski R, Schreeder M, Mallidi PV, Greco FA; Minnie Pearl Cancer Research Network. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol. 2007 Sep;2(9):854-61. doi: 10.1097/JTO.0b013e31814617b7.

Helpful Links

• Published article in the Journal of Thoracic Oncology

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 28, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Irinotecan; Imatinib Mesylate
• Other Study ID Numbers: SCRI LUN 59; CSTI571BUS66; CPTAIV-0020-403