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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00698815 |
RATIONALE: Drugs used in chemotherapy, such as pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed together with sunitinib may kill more tumor cells. It is not yet known whether pemetrexed and sunitinib are more effective when given alone or together in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying pemetrexed and sunitinib to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: pemetrexed disodium Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib (NSC # 736511, IND # 74019) or Pemetrexed Plus Sunitinib in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 225 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in arm II as third-line therapy.
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Drug: pemetrexed disodium
Given IV
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Arm II: Experimental
Patients receive oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in arm I as third-line therapy.
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Drug: sunitinib malate
Given orally
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Arm III: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
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Drug: pemetrexed disodium
Given IV
Drug: sunitinib malate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), disease stage (IIIB vs IV), and gender.
Patients are randomized to 1 of 3 treatment arms.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Measurable or non-measurable disease
Non-measurable disease is defined as all other lesions, including small lesions (i.e., longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan) and truly non-measurable lesions, including any of the following:
No symptomatic or untreated CNS metastases
PATIENT CHARACTERISTICS:
No symptomatic congestive heart failure within the past 12 months
Patients with a history of NYHA class II heart failure are eligible provided at least 1 of the following criteria is met:
No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis
PRIOR CONCURRENT THERAPY:
At least 28 days since prior first-line therapy
More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent therapeutic anticoagulation for thromboembolic disease
Study Chair: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Investigator: | Rebecca S. Heist, MD | Harvard School of Public Health |
Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
Study ID Numbers: | CDR0000589102, CALGB-30704 |
Study First Received: | June 14, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00698815 History of Changes |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Antimetabolites Thoracic Neoplasms Folic Acid Antagonists Angiogenesis Inhibitors Recurrence Carcinoma Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Sunitinib Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Sunitinib Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |