Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-27 @ 3:14 AM
Study NCT ID:
NCT00551733
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2007-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Sponsor:
CTI BioPharma
Organization:
Study Overview
Official Title:
Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL
Status:
TERMINATED
Status Verified Date:
2020-10
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:
RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving carboplatin together with paclitaxel poliglumex is more effective than giving carboplatin together with paclitaxel in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.
Secondary
* Compare the progression-free survival of women treated with these regimens.
* Compare the disease control in women treated with these regimens.
* Compare the clinical benefit in women treated with these regimens.
* Compare the response rate in women treated with these regimens.
* Compare the quality of life of women treated with these regimens.
* Compare the safety and tolerability in women treated with these regimens.
OUTLINE: This is a multicenter study.
Patients are stratified according to age (≥ 60 vs \< 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).
After completion of study therapy, patients are followed at least monthly.
Primary
* Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.
Secondary
* Compare the progression-free survival of women treated with these regimens.
* Compare the disease control in women treated with these regimens.
* Compare the clinical benefit in women treated with these regimens.
* Compare the response rate in women treated with these regimens.
* Compare the quality of life of women treated with these regimens.
* Compare the safety and tolerability in women treated with these regimens.
OUTLINE: This is a multicenter study.
Patients are stratified according to age (≥ 60 vs \< 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
* Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).
After completion of study therapy, patients are followed at least monthly.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: