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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00454194 |
RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying pemetrexed disodium and sorafenib to see how well they work compared with pemetrexed disodium alone 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: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase II Randomized Study of Pemetrexed With Sorafenib Versus Pemetrexed Alone as Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 104 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: pemetrexed disodium
given IV
Drug: sorafenib tosylate
given orally
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Arm II: 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.
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Drug: pemetrexed disodium
given IV
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and North Central Cancer Treatment Group membership. Patients are randomized to 1 of 2 treatment arms.
Blood and tissue samples are collected for pharmacokinetic analysis and research studies. Gene expression assays and polymorphism studies (e.g., using polymerase chain reaction) of circulating peripheral blood mononuclear cells are conducted for reduced folate carrier, multidrug resistance-associated protein, folate receptor, BCRP, folylpolyglutamate synthase, MTHFR, methionine synthase, methylthioadenosine phosphorylase, TS, dihydrofolate reductase, GARFT, endothelial nitric oxide synthase, angiotensinogen, dimethylarginine dimethylaminohydrolase, vascular endothelial growth factor (VEGF), and VEGF receptor. Enzyme-linked immunosorbent assays and immunohistochemistry are also conducted.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 104 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-squamous cell histologic type non-small cell lung cancer (NSCLC)
Mixed histology allowed if all components consistent with NSCLC
Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
No nonmeasurable disease only, including small lesions and truly nonmeasurable lesions, including any of the following:
Previously treated with 1 chemotherapy regimen, including adjuvant treatment
Symptomatic pleural effusions should be drained prior to study entry
Stable brain metastasis allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
No second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
No concurrent severe and/or uncontrolled medical conditions, including any of the following:
PRIOR CONCURRENT THERAPY:
Prior radiotherapy allowed if all the following criteria are met:
No concurrent therapeutic anticoagulation
Study Chair: | Alex A. Adjei, MD, PhD | Roswell Park Cancer Institute |
Investigator: | Grace K. Dy, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000536546, NCCTG-N0626 |
Study First Received: | March 27, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00454194 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer squamous cell lung cancer |
adenosquamous cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer |
Antimetabolites Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Folic Acid Antagonists Protein Kinase Inhibitors Recurrence Carcinoma Folic Acid Pemetrexed |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Sorafenib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |