A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer
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Purpose
The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-small-cell Lung |
Drug: Bexarotene (targretin) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I and II Clinical Studies of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules for the Treatment of Patients With Advanced Non-Small Cell Lung Cancer |
- To evaluate the safety of administering bexarotene oral capsules (Targretin) daily at two dose levels in combination with carboplatin (Paraplatin) and two schedules of Taxol in advanced non-small cell lung cancer. [ Time Frame: Begining of enrollment to accrual of patients and data analysis ] [ Designated as safety issue: No ]
- To evaluate the preliminary efficacy of bexarotene oral capsules (Targretin) in combination with carboplatin (Paraplatin) and weekly Taxol given every 4 weeks in advanced non-small cell lung cancer (Phase II component). [ Time Frame: Enrollment of first subject to accural of subjects/ data analysis. ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | August 2001 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
|
Drug: Bexarotene (targretin)
Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). Level 1: 300mg Level 2: 400mg Other Name: Targretin, LGD1069
|
Detailed Description:
The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.
The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- unresectable stage IIIB or IV NSCLC
- adequate bone marrow, hepatic, thyroid and renal function
Exclusion Criteria:
- peripheral neuropathy >= grade 2
- gastrointestinal abnormalities
- known hypersensitivity to retinoids
Contacts and Locations| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Principal Investigator: | James R Rigas, MD | Norris Cotton Cancer Center |
More Information
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00153842 History of Changes |
| Other Study ID Numbers: | D-0109 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
NSCLC Bexarotene Targretin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Bexarotene |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013