Ignite Creation Date:
2025-12-18 @ 9:19 AM
Ignite Modification Date:
2025-12-23 @ 5:41 PM
Study NCT ID:
NCT00795340
Status:
None
Last Update Posted:
2023-08-22 00:00:00
First Post:
2008-11-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Double Blind Randomized Trial of Cediranib Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
None
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES:
Primary
* To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carboplatin.
Secondary
* To compare the progression-free survival of patients treated with these regimens.
* To compare the objective response rates in patients treated with these regimens.
* To estimate time to response and response duration in patients treated with these regimens.
* To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis, in patients treated with these regimens.
* To compare the pharmacokinetics of paclitaxel between the two arms in a subset of enrolled patients
* To compare the quality of life of patients treated with these regimens.
* To determine the incremental cost effectiveness and cost utility ratios for these regimens.
* To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion OUTLINE: This is a multicenter study. Patients are stratified by gender, center, disease stage (IIIB vs IV), weight loss (\< 5% vs 5-10% vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
Treatment in both arms repeats every 21 days for 4 to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and periodically thereafter.
After completion of study therapy, patients are followed every 12 weeks.
Primary
* To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carboplatin.
Secondary
* To compare the progression-free survival of patients treated with these regimens.
* To compare the objective response rates in patients treated with these regimens.
* To estimate time to response and response duration in patients treated with these regimens.
* To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis, in patients treated with these regimens.
* To compare the pharmacokinetics of paclitaxel between the two arms in a subset of enrolled patients
* To compare the quality of life of patients treated with these regimens.
* To determine the incremental cost effectiveness and cost utility ratios for these regimens.
* To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion OUTLINE: This is a multicenter study. Patients are stratified by gender, center, disease stage (IIIB vs IV), weight loss (\< 5% vs 5-10% vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
Treatment in both arms repeats every 21 days for 4 to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and periodically thereafter.
After completion of study therapy, patients are followed every 12 weeks.
Detailed Description:
None
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?: