Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
- Conditions
- Lung CancerDrug/Agent Toxicity by Tissue/OrganRadiation Toxicity
- Interventions
- Biological: filgrastimRadiation: radiation therapy
- Registration Number
- NCT00006012
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after radiation therapy in treating patients who have limited-stage small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of thoracic radiotherapy administered with cisplatin, etoposide, and amifostine preceded and followed by topotecan and paclitaxel in patients with limited stage small cell lung cancer (phase I closed to accrual as of 5/27/2004).
* Determine the two-year survival of this patient population treated with this regimen.
* Determine the two-year, progression-free local control rate in this patient population treated with this regimen.
* Assess the tolerability of this treatment regimen in these patients.
* Determine the antitumor activity of this regimen in these patients.
* Determine the overall survival and overall time to progression in this patient population treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses.
After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT.
At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.
Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed to accrual as of 5/27/2004).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description topotecan + paclitaxel + filgrastim + TRT + radiation amifostine trihydrate Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation topotecan hydrochloride Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation paclitaxel Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation radiation therapy Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation filgrastim Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation cisplatin Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. topotecan + paclitaxel + filgrastim + TRT + radiation etoposide Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses. After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT. At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
- Primary Outcome Measures
Name Time Method Survival at 2 years at 2 years
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5 years Time to progression Up to 5 years Local progression-free survival at 2 years at 2 years
Trial Locations
- Locations (84)
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare
🇺🇸La Crosse, Wisconsin, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Bryan LGH Medical Center West
🇺🇸Lincoln, Nebraska, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States