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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Cell Therapeutics |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00487669 |
This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.
Condition | Intervention | Phase |
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Advanced Non-Small Cell Lung Cancer |
Drug: paclitaxel poliglumex, pemetrexed |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-Small Cell Lung Cancer. |
Estimated Enrollment: | 45 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than
1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued
Primary objective
To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.
Secondary Objectives
To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.
To evaluate the duration of response, time to progression, and overall survival of advanced NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.
To compare the overall response rate using three-dimensional reconstruction of target lesions by Medical Metrx Solutions (MMS) and RECIST criteria.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: | James R Rigas, MD | Norriss Cotten Cancer Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center ( James R. Rigas, MD ) |
Study ID Numbers: | D-0433 |
Study First Received: | June 14, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00487669 History of Changes |
Health Authority: | United States: Food and Drug Administration |
paclitaxel poliglumex xyotax alimta advanced non-small cell lung cancer |
Antimetabolites Thoracic Neoplasms Folate Antimitotic Agents Folinic Acid Folic Acid Antagonists Vitamin B9 Carcinoma Folic Acid Pemetrexed |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators 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 |