Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073385
Status:
COMPLETED
Last Update Posted:
2005-08-30
First Post:
2003-11-19
Brief Title:
Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Titan Pharmaceuticals
Organization:
Titan Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Rationale Pivanex is a histone deacetylase inhibitor that induces tumor differentiation andor 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
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 CRPRSD 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
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
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 CRPRSD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSCLC Clincal Trial | None | None | None |