Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00073385|
Recruitment Status : Completed
First Posted : November 21, 2003
Last Update Posted : August 30, 2005
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Pivanex Drug: Docetaxel||Phase 2|
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.
- Compare the survival of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone
- Compare the time to disease progression, tumor responses, and safety profile of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone
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.
- Arm A: Patients receive the combination of Pivanex intravenously on Days 1-3 and docetaxel intravenously on Day 4. Treatment repeats every 21 days until disease progression or treatment withdrawal.
- Arm B: Patients receive docetaxel intravenously on Day 1. Treatment repeats every 21 days until disease progression or treatment withdrawal.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||September 2003|
|Study Completion Date :||October 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073385
|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|
|Montefiore Medical Center, Department of Oncology|
|Bronx, New York, United States, 10467|
|Brooklyn, New York, United States, 11235|
|United States, North Carolina|
|Gaston Hematology & Oncology Associates|
|Gastonia, North Carolina, United States, 28054|
|Rajiv Gandhi Cancer Institute & Research Center|
|New Delhi, India, 110 085|
|Regional Cancer Centre|
|Thiruvananthapuram, India, 695 011|
|University of Edinburgh, Edinburgh Cancer Centre|
|Edinburgh, United Kingdom, EH4 2XU|