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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00438204 |
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Biological: bevacizumab Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 42 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes, gemcitabine hydrochloride IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 42 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 nonsquamous cell non-small cell lung cancer (NSCLC), including the following cell types:
Stage IIIB or IV NSCLC
Unidimensionally measurable or evaluable disease
No CNS or untreated brain metastases
Treated brain metastases allowed provided there is no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as determined by clinical examination and brain imaging (MRI or CT) during the screening period
PATIENT CHARACTERISTICS:
No significant cardiovascular illness, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0942 | |
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 |
Study Chair: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Barbara Ann Karmanos Cancer Institute ( Antoinette J. Wozniak ) |
Study ID Numbers: | CDR0000531832, WSU-2005-008, WSU-036806MP4F |
Study First Received: | February 20, 2007 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00438204 History of Changes |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
bronchoalveolar cell lung cancer large cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Folate Bevacizumab Vitamin B9 Respiratory Tract Diseases Lung Neoplasms Gemcitabine Adenocarcinoma, Bronchiolo-Alveolar Folic Acid Antagonists Folinic Acid Antiviral Agents |
Immunosuppressive Agents Angiogenesis Inhibitors Recurrence Carcinoma Pemetrexed Folic Acid Radiation-Sensitizing Agents Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Folic Acid Antagonists Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Radiation-Sensitizing Agents Lung Diseases |