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Sponsors and Collaborators: |
University of California, Davis National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470548 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: pemetrexed disodium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer |
Estimated Enrollment: | 73 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by an open-label, phase II study.
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 73 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:
Cytologically or histologically proven advanced non-small cell lung cancer (NSCLC), breast cancer, or other solid tumors (phase I)
Cytologically or histologically proven NSCLC, meeting all of the following criteria (phase II):
Stage IIIB (pleural effusion) or IV disease
Must have measurable disease by RECIST criteria
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No more than 2 prior chemotherapy regimens for advanced NSCLC (phase II)
United States, California | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 |
Study Chair: | David R. Gandara, MD | University of California, Davis |
Investigator: | Corinne Turrell, CCRP | University of California, Davis |
Responsible Party: | University of California Davis Cancer Center ( David R. Gandara ) |
Study ID Numbers: | CDR0000542904, UCD-185, UCD-200614714 |
Study First Received: | May 3, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00470548 History of Changes |
Health Authority: | Unspecified |
male breast cancer recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer unspecified adult solid tumor, protocol specific |
Antimetabolites Thoracic Neoplasms Skin Diseases Breast Neoplasms Antimitotic Agents Breast Cancer, Male Folic Acid Antagonists Recurrence Carcinoma Folic Acid Pemetrexed |
Breast Neoplasms, Male Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Breast Diseases Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Breast Diseases Respiratory Tract Neoplasms Neoplasms by Histologic Type Skin Diseases Mitosis Modulators |
Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |