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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B National Cancer Institute of Canada North Central Cancer Treatment Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324805 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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 also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: vinorelbine ditartrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non-Small Lung Cancer (NSCLC) |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1, docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
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Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: docetaxel
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: paclitaxel
Given IV
Drug: vinorelbine ditartrate
Given IV
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Arm II: Experimental
Patients receive chemotherapy as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.
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Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: docetaxel
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: paclitaxel
Given IV
Drug: vinorelbine ditartrate
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride), stage (IB vs II vs IIIA [N2] vs IIIA [T3, N1]), histology (squamous cell vs other), and gender. Patients are randomized to 1 of 2 treatment arms.
Arm I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 3 chemotherapy regimens.
In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients complete smoking status questionnaires at baseline and then every 3 months during study treatment.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 1,500 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:
Diagnosis of stage IB-IIIA (T2-3 N0, T1-3 N1, T1-3 N3) non-small cell lung cancer (NSCLC)
Must have undergone complete resection of NSCLC within the past 6-12 weeks
Accepted types of resection include any of the following:
PATIENT CHARACTERISTICS:
No uncontrolled hypertension
PRIOR CONCURRENT THERAPY:
No hormonal cancer therapy or radiotherapy as cancer treatment within the past 5 years
No major surgery or open biopsy within the past 28 days
Study Chair: | Heather A. Wakelee, MD | Stanford University |
Investigator: | Alan B. Sandler, MD | Vanderbilt-Ingram Cancer Center |
Study Chair: | David R. Gandara, MD | University of California, Davis |
Investigator: | Eric Vallieres, MD, FRCSC | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
Study Chair: | Stephen L. Graziano, MD | State University of New York - Upstate Medical University |
Study Chair: | Charles A. Butts, MD, FRCPC | Cross Cancer Institute at University of Alberta |
Study Chair: | Alex A. Adjei, MD, PhD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000475774, ECOG-E1505, SWOG-E1505, CALGB-E1505, CAN-NCIC-E1505, NCCTG-E1505 |
Study First Received: | May 10, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00324805 |
Health Authority: | Unspecified |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Vinblastine Bevacizumab Carboplatin Docetaxel Vinorelbine |
Respiratory Tract Diseases Cisplatin Lung Neoplasms Paclitaxel Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |