Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00054210|
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : July 24, 2008
|First Submitted Date ICMJE||February 5, 2003|
|First Posted Date ICMJE||February 6, 2003|
|Last Update Posted Date||July 24, 2008|
|Study Start Date ICMJE||January 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00054210 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Polyglutamate Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer|
|Official Title ICMJE||CT-2103/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Treatment repeats in both arms every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 13 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Lung Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada, United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00054210|
|Other Study ID Numbers ICMJE||CDR0000269910
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||CTI BioPharma|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||July 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP