Spots Global Cancer Trial Database for Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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
Study ID: NCT00551733
Conditions
Study Description
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Scottsdale Medical Specialists, Scottsdale, Arizona, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, Burbank, California, United States
Southwest Cancer Care - Escondido, Escondido, California, United States
Clinical Trials and Research Associates, Incorporated, Montebello, California, United States
Stanford Cancer Center, Stanford, California, United States
Broward Oncology Associates, Fort Lauderdale, Florida, United States
Horizon Institute for Clinical Research, Hollywood, Florida, United States
Rush Cancer Institute at Rush University Medical Center, Chicago, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
Hematology Oncology Consultants - Naperville, Naperville, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois, United States
Cancer Center of Indiana, New Albany, Indiana, United States
Providence Medical Group, Terre Haute, Indiana, United States
Family Medicine of Vincennes Clinical Trial Center, Vincennes, Indiana, United States
West Michigan Regional Cancer and Blood Center, Free Soil, Michigan, United States
Newland Medical Associates PC - Southfield, Southfield, Michigan, United States
Hattiesburg Clinic, PA at Forrest General, Hattiesburg, Mississippi, United States
Columbia Comprehensive Cancer Care Clinic, Columbia, Missouri, United States
Kansas City Cancer Centers - South, Kansas City, Missouri, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Las Vegas Cancer Center, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Reno, Reno, Nevada, United States
Lincoln Medical and Mental Health Center, Bronx, New York, United States
Richmond University Medical Center, Staten Island, New York, United States
New York Medical College, Valhalla, New York, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
Blood and Cancer Center, Incorporated, Canfield, Ohio, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Vita Hematology Oncology at St. Luke's Hospital, Bethlehem, Pennsylvania, United States
Cancer Centers of the Carolinas - Eastside, Greenville, South Carolina, United States
Family Cancer Center, PLLC - Collierville, Collierville, Tennessee, United States
Mid-South Cancer Center, Germantown, Tennessee, United States
Southwest Regional Cancer Center - Central, Austin, Texas, United States
Lone Star Oncology - Austin, Austin, Texas, United States
Mary Crowley Medical Research Center at Sammons Cancer Center, Dallas, Texas, United States
Utah Hematology Oncology, PC, Ogden, Utah, United States
Cancer Outreach Associates - Abingdon, Abingdon, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Cell Therapeutics, Incorporated, Seattle, Washington, United States
Contact Details
Name: Fred B. Oldham, MD
Affiliation: CTI BioPharma
Role: STUDY_CHAIR
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