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Sponsored by: |
Titan Pharmaceuticals |
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Information provided by: | Titan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00073385 |
This randomized study will assess the efficacy and safety of the combination of Pivanex and docetaxel compared to docetaxel alone in patients with a type of lung cancer called non-small cell lung cancer. Pivanex is an investigational agent, and docetaxel is an approved drug.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Pivanex Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC) |
Estimated Enrollment: | 225 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | October 2004 |
Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation and/or apoptosis. Pivanex has been well tolerated in clinical trials and has shown preliminary evidence of efficacy in patients with non-small cell lung cancer. Docetaxel is an approved drug for second-line treatment of non-small cell lung cancer. Preclinical studies indicate that the combination of Pivanex and docetaxel is synergistic.
Purpose: This open-label randomized trial will evaluate whether combination therapy with Pivanex and docetaxel provides clinical benefit over docetaxel alone in patients with chemotherapy resistant non-small cell lung cancer.
Objectives:
Outline: This is a randomized, open-label, multicenter study in patients with non-small cell lung cancer who have previously been treated with no more than one prior platinum containing chemotherapy regimen. Patients are stratified by ECOG performance status (0-1 vs. 2), response to prior platinum based chemotherapy (progression vs. CR/PR/SD) and prior taxane therapy (yes vs. no). Patients are randomized to 1 of 2 treatment arms.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Treatment with one prior platinum-based chemotherapy regimen (Eligible patients may include:
Exclusion Criteria:
United States, California | |
Wilshire Oncology Medical Group | |
La Verne, California, United States, 91750 | |
United States, Louisiana | |
Hematology and Oncology Specialists, LLC | |
New Orleans, Louisiana, United States, 70115 | |
United States, New York | |
HemOnCare | |
Brooklyn, New York, United States, 11235 | |
Montefiore Medical Center, Department of Oncology | |
Bronx, New York, United States, 10467 | |
United States, North Carolina | |
Gaston Hematology & Oncology Associates | |
Gastonia, North Carolina, United States, 28054 | |
India | |
Rajiv Gandhi Cancer Institute & Research Center | |
New Delhi, India, 110 085 | |
Regional Cancer Centre | |
Thiruvananthapuram, India, 695 011 | |
United Kingdom | |
University of Edinburgh, Edinburgh Cancer Centre | |
Edinburgh, United Kingdom, EH4 2XU |
Study ID Numbers: | TTP-200-03-01, NSCLC Clincal Trial |
Study First Received: | November 19, 2003 |
Last Updated: | August 26, 2005 |
ClinicalTrials.gov Identifier: | NCT00073385 |
Health Authority: | United States: Food and Drug Administration |
Lung cancer, Docetaxel, Histone deacetylase inhibitor |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |