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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00438204 |
Purpose
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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 27 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | June 2012 (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.
Eligibility| 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:
Contacts and 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 | |
| Study Chair: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Responsible Party: | Antoinette J. Wozniak, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00438204 History of Changes |
| Other Study ID Numbers: | CDR0000531832, P30CA022453, WSU-2005-008, WSU-036806MP4F |
| Study First Received: | February 20, 2007 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
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 |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed Bevacizumab Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Folic Acid Antagonists Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |