Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Vereinigte Staaten, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Vereinigte Staaten, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Vereinigte Staaten, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Vereinigte Staaten, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Vereinigte Staaten, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Miami Beach, Florida, Vereinigte Staaten, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Vereinigte Staaten, 60637
- University of Chicago Cancer Research Center
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Chicago, Illinois, Vereinigte Staaten, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242
- University of Iowa Hospitals and Clinics
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Maine
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Togus, Maine, Vereinigte Staaten, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Vereinigte Staaten, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, Vereinigte Staaten, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Vereinigte Staaten, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, Vereinigte Staaten, 63131
- Missouri Baptist Cancer Center
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Vereinigte Staaten, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Vereinigte Staaten, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Vereinigte Staaten, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Vereinigte Staaten, 11030
- North Shore University Hospital
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New York, New York, Vereinigte Staaten, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Vereinigte Staaten, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Vereinigte Staaten, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Vereinigte Staaten, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Vereinigte Staaten, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Vereinigte Staaten, 13210
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Vereinigte Staaten, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Vereinigte Staaten, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 38104
- Veterans Affairs Medical Center - Memphis
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Memphis, Tennessee, Vereinigte Staaten, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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Burlington, Vermont, Vereinigte Staaten, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Vereinigte Staaten, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Vereinigte Staaten, 23249
- Veterans Affairs Medical Center - Richmond
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited stage small cell lung cancer Includes disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes Clinically suspected or confirmed supraclavicular lymph node metastases and pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible Unidimensionally or bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent active second malignancy except nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30% risk of relapse)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent steroids except for adrenal failure No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone except for intermittent use as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: No prior mediastinal radiotherapy Surgery: Not specified
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: chemotherapy + radiation therapy
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Rücklaufquote
Zeitfenster: Bis zu 5 Jahre
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Bis zu 5 Jahre
|
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Gesamtüberleben
Zeitfenster: Bis zu 5 Jahre
|
Bis zu 5 Jahre
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Alan P. Lyss, MD, Missouri Baptist Cancer Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Bogart JA, Herndon JE 2nd, Lyss AP, Watson D, Miller AA, Lee ME, Turrisi AT, Green MR; Cancer and Leukemia Group B study 39808. 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small-cell lung cancer: analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):460-8. doi: 10.1016/j.ijrobp.2003.10.021.
- Cicchetti MG, Bogart J, Lyss A, et al.: Spinal cord dose in limited stage small cell lung cancer: a preliminary Quality Assurance Review Committee (QARC) report on CALGB 39808, using target thoracic radiotherapy (TRT) doses of 60 - 70 Gy. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-656, 356, 2001.
- Lyss AP, Herndon JE, Bogart JE, et al.: Topotecan (Topo) + paclitaxel (Tax) + G-CSF (G) induction followed by concurrent chemoradiotherapy (CCRT) for patients (pts) with limited stage small cell lung cancer (L-SCLC): preliminary analysis of CALGB 39808. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1270, 2001.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Kleinzelliges Lungenkarzinom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Topoisomerase I-Inhibitoren
- Carboplatin
- Etoposid
- Paclitaxel
- Topotecan
Andere Studien-ID-Nummern
- CALGB-39808
- U10CA031946 (US NIH Stipendium/Vertrag)
- CLB-39808
- CDR0000066958 (Registrierungskennung: NCI Physician Data Query)
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