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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) National Comprehensive Cancer Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00729612 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, 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.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies |
Estimated Enrollment: | 63 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary Objectives
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
No uncontrolled brain metastases (or leptomeningeal disease)
Controlled brain metastases allowed
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Gregory A. Otterson, MD 866-627-7616 osu@emergingmed.com |
Principal Investigator: | Gregory A. Otterson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Principal Investigator: | Gregory A. Otterson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Gregory A. Otterson ) |
Study ID Numbers: | CDR0000602242, OSU-08059, NCCN-AO8 |
Study First Received: | August 6, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00729612 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Hemorrhage Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |