Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer focused on measuring extensive stage small cell lung cancer, Topotecan, Etoposide, Cisplatin, Irinotecan
Eligibility Criteria
INCLUSION CRITERIA: Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 Disease-free for >=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if no demonstrable liver metastases or <=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance >=30 using the formulas in the protocol Age 18 and older Strongly advised to use an accepted and effective method of contraception Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy Those receiving erythropoietin could continue to receive it EXCLUSION CRITERIA: Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases Prior chemotherapy for this disease Pregnant or lactating
Sites / Locations
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Baptist Cancer Institute - Jacksonville
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Medical Center of Central Georgia
- Rush-Copley Cancer Care Center
- Joliet Oncology-Hematology Associates, Limited - West
- Hematology & Oncology Care
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- Swedish-American Regional Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Clarian Arnett Cancer Care
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Program at Union Hospital
- Frederick Memorial Hospital Regional Cancer Therapy Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey at Hamilton
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Case Comprehensive Cancer Center
- St. Rita's Medical Center
- Bryn Mawr Hospital
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
- Central Pennsylvania Hematology and Medical Oncology Associates, PC
- Cancer Center of Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
- Chester County Hospital
- CCOP - MainLine Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Regional Cancer Center at Sacred Heart Hospital
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic - Weston Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
PET (Topotecan/Etoposide/Cisplatin/G-CSF)
PIE (Irinotecan/Cisplatin/Etoposide)
Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.