Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00955305 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 and cixutumumab, 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. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying giving paclitaxel and carboplatin together with bevacizumab to see how well it works when given with or without cixutumumab in treating patients with stage IV or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Biological: bevacizumab Biological: cixutumumab Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-Squamous Non- Small Cell Lung Cancer |
Estimated Enrollment: | 180 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
Arm II: Experimental
Patients receive paclitaxel, carboplatin, and bevacizumab as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15.
|
Biological: bevacizumab
Given IV
Biological: cixutumumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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, non-small cell lung cancer (NSCLC), including any of the following subtypes*:
Advanced disease, as defined by any of the following:
Measurable disease, as defined by RECIST (PET and the PET portion of PET/CT are not acceptable methods of evaluation for response)
Brain metastases are allowed, provided they have been treated with surgery and/or radiotherapy, the patient is neurologically stable, and repeat brain imaging shows no progression in the brain
PATIENT CHARACTERISTICS:
No poorly controlled diabetes mellitus
No history of other invasive malignancies unless there is no active disease and all treatment has been completed > 3 years prior to study
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000651469, ECOG-E3508 |
Study First Received: | August 7, 2009 |
Last Updated: | September 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00955305 History of Changes |
Health Authority: | Unspecified |
stage IV non-small cell lung cancer recurrent non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer |
Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Antimitotic Agents Carboplatin Bevacizumab Angiogenesis Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances |
Mitosis Modulators Carboplatin Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |