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
- 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.
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Fred B. Oldham, MD
|Joliet Oncology-Hematology Associates, Limited - West||Joliet, Illinois 60435|
|Aultman Cancer Center at Aultman Hospital||Canton, Ohio 44710-1799|
|New York Medical College||Valhalla, New York 10595|
|Virginia Mason Medical Center||Seattle, Washington 98111|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Columbia Comprehensive Cancer Care Clinic||Columbia, Missouri 65201|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Hematology Oncology Consultants - Naperville||Naperville, Illinois 60540|
|Stanford Cancer Center||Stanford, California 94305-5824|
|Mid Dakota Clinic, PC||Bismarck, North Dakota 58501|
|Saint Louis University Cancer Center||Saint Louis, Missouri 63110|
|Lincoln Medical and Mental Health Center||Bronx, New York 10451|
|Veterans Affairs Medical Center - Reno||Reno, Nevada 89520|
|Rush Cancer Institute at Rush University Medical Center||Chicago, Illinois 60612|
|Cancer Centers of the Carolinas - Eastside||Greenville, South Carolina 29601|
|Hattiesburg Clinic, PA at Forrest General||Hattiesburg, Mississippi 39401|
|Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields||Olympia Fields, Illinois 60461|
|Broward Oncology Associates||Ft. Lauderdale, Florida 33308|
|West Michigan Regional Cancer and Blood Center||Ludington, Michigan 49431|
|Las Vegas Cancer Center||Las Vegas, Nevada 89102|
|Clinical Trials and Research Associates, Incorporated||Montebello, California 90640|
|Cancer Center of Indiana||New Albany, Indiana 47150|
|Family Cancer Center, PLLC - Collierville||Collierville, Tennessee 38077|
|Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center||Burbank, California 91505|
|Southwest Regional Cancer Center - Central||Austin, Texas 78705|
|Mary Crowley Medical Research Center at Sammons Cancer Center||Dallas, Texas 75246|
|Providence Medical Group||Terre Haute, Indiana 47802|
|Vita Hematology Oncology at St. Luke's Hospital||Bethlehem, Pennsylvania 18015|
|Richmond University Medical Center||Staten Island, New York 10310-1699|
|Kansas City Cancer Centers - South||Kansas City, Missouri 64131|
|Family Medicine of Vincennes Clinical Trial Center||Vincennes, Indiana 47591|
|Cancer Outreach Associates - Abingdon||Abingdon, Virginia 24211|
|Lone Star Oncology - Austin||Austin, Texas 78759|
|Mid-South Cancer Center||Germantown, Tennessee 38138|
|Horizon Institute for Clinical Research||Hollywood, Florida 33021|
|Scottsdale Medical Specialists||Scottsdale, Arizona 85258|
|Cell Therapeutics, Incorporated||Seattle, Washington 98119|
|Southwest Cancer Care - Escondido||Escondido, California 92025-4404|
|Newland Medical Associates PC - Southfield||Southfield, Michigan 48275|
|Blood and Cancer Center, Incorporated||Canfield, Ohio 44406|
|Utah Hematology Oncology, PC||Ogden, Utah 84403|