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Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study (NCT00003812)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use 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 more than one drug and giving them before and with radiation therapy may be an effective treatment for limited-stage small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
  • Biological: filgrastim
    • Drug: carboplatin
      • Drug: etoposide
        • Drug: paclitaxel
          • Drug: topotecan hydrochloride
            • Radiation: radiation therapy
              Ages eligible for Study
              18 Years and older
              Genders eligible for Study
              All
              Accepts Healthy Volunteers
              No
              OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan followed by consolidation chemoradiotherapy in patients with limited stage small cell lung cancer. II. Determine the toxic effects of this regimen in this patient population. III. Describe the pattern of relapse, documenting carefully the location of relapse with respect to the original disease volume and the radiation treatment field in these patients. IV. Determine the overall and failure free survival of these patients.

              OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.

              PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18 months.

              48 locations

              United States (48)
              • Veterans Affairs Medical Center - Birmingham
                Birmingham, Alabama, United States, 35233
              • University of California San Diego Cancer Center
                La Jolla, California, United States, 92093-0658
              • UCSF Cancer Center and Cancer Research Institute
                San Francisco, California, United States, 94115-0128
              • Veterans Affairs Medical Center - San Francisco
                San Francisco, California, United States, 94121
              • CCOP - Christiana Care Health Services
                Wilmington, Delaware, United States, 19899
              • Vincent T. Lombardi Cancer Research Center, Georgetown University
                Washington, District of Columbia, United States, 20007
              • Walter Reed Army Medical Center
                Washington, District of Columbia, United States, 20307-5000
              • CCOP - Mount Sinai Medical Center
                Miami Beach, Florida, United States, 33140
              • University of Illinois at Chicago Health Sciences Center
                Chicago, Illinois, United States, 60612
              • Veterans Affairs Medical Center - Chicago (Westside Hospital)
                Chicago, Illinois, United States, 60612
              • University of Chicago Cancer Research Center
                Chicago, Illinois, United States, 60637
              • University of Iowa Hospitals and Clinics
                Iowa City, Iowa, United States, 52242
              • Veterans Affairs Medical Center - Togus
                Togus, Maine, United States, 04330
              • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
                Baltimore, Maryland, United States, 21201
              • Dana-Farber Cancer Institute
                Boston, Massachusetts, United States, 02115
              • University of Massachusetts Memorial Medical Center
                Worcester, Massachusetts, United States, 01655
              • Veterans Affairs Medical Center - Minneapolis
                Minneapolis, Minnesota, United States, 55417
              • Veterans Affairs Medical Center - Columbia (Truman Memorial)
                Columbia, Missouri, United States, 65201
              • Ellis Fischel Cancer Center - Columbia
                Columbia, Missouri, United States, 65203
              • Barnes-Jewish Hospital
                Saint Louis, Missouri, United States, 63110
              • Missouri Baptist Cancer Center
                Saint Louis, Missouri, United States, 63131
              • University of Nebraska Medical Center
                Omaha, Nebraska, United States, 68198-3330
              • CCOP - Southern Nevada Cancer Research Foundation
                Las Vegas, Nevada, United States, 89106
              • Norris Cotton Cancer Center
                Lebanon, New Hampshire, United States, 03756
              • Veterans Affairs Medical Center - Buffalo
                Buffalo, New York, United States, 14215
              • Roswell Park Cancer Institute
                Buffalo, New York, United States, 14263-0001
              • CCOP - North Shore University Hospital
                Manhasset, New York, United States, 11030
              • North Shore University Hospital
                Manhasset, New York, United States, 11030
              • Memorial Sloan-Kettering Cancer Center
                New York, New York, United States, 10021
              • New York Presbyterian Hospital - Cornell Campus
                New York, New York, United States, 10021
              • Mount Sinai Medical Center, NY
                New York, New York, United States, 10029
              • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
                Syracuse, New York, United States, 13210
              • State University of New York - Upstate Medical University
                Syracuse, New York, United States, 13210
              • Veterans Affairs Medical Center - Syracuse
                Syracuse, New York, United States, 13210
              • Lineberger Comprehensive Cancer Center, UNC
                Chapel Hill, North Carolina, United States, 27599-7295
              • Veterans Affairs Medical Center - Durham
                Durham, North Carolina, United States, 27705
              • Duke Comprehensive Cancer Center
                Durham, North Carolina, United States, 27710
              • CCOP - Southeast Cancer Control Consortium
                Winston-Salem, North Carolina, United States, 27104-4241
              • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
                Winston-Salem, North Carolina, United States, 27157-1082
              • Arthur G. James Cancer Hospital - Ohio State University
                Columbus, Ohio, United States, 43210
              • Rhode Island Hospital
                Providence, Rhode Island, United States, 02903
              • Medical University of South Carolina
                Charleston, South Carolina, United States, 29425-0721
              • Veterans Affairs Medical Center - Memphis
                Memphis, Tennessee, United States, 38104
              • University of Tennessee, Memphis Cancer Center
                Memphis, Tennessee, United States, 38163
              • Vermont Cancer Center
                Burlington, Vermont, United States, 05401-3498
              • Veterans Affairs Medical Center - White River Junction
                White River Junction, Vermont, United States, 05009
              • Veterans Affairs Medical Center - Richmond
                Richmond, Virginia, United States, 23249
              • MBCCOP - Massey Cancer Center
                Richmond, Virginia, United States, 23298-0037
              Status:
              completed
              Type:
              Interventional
              Phase:
              Start:
              28 February, 1999
              Updated:
              18 July, 2016
              Participants:
              75
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