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- Register voor klinische proeven in de VS.
- Klinische proef NCT00003172
Comparison of Combination Chemotherapy Regimens in Treating Patients With Advanced Stomach Cancer
Randomized Phase II Trial of Either 5-Fluorouracil, Recombinant Alfa-2a-Interferon and Intravenous Hydroxyurea With Filgrastim Support (FHIG) or Doxorubicin/Docetaxel (Dd) in Patients With Advanced Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different combinations and combining them with interferon alfa and G-CSF may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating patients with advanced stomach cancer.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
OBJECTIVES: I. Evaluate the objective response rates for two different regimens in patients with advanced gastric cancer: the combination of fluorouracil plus hydroxyurea given as high dose 24 hour infusions plus interferon alfa-2a and filgrastim; versus the combination of doxorubicin and docetaxel. II. Evaluate the toxicities and reversibility of toxicities of each of these combinations in patients with advanced gastric cancer.
OUTLINE: This is an open label, two arm, multicenter, randomized study. Arm I: Patients receive fluorouracil (5-FU), recombinant alfa-2a interferon, hydroxyurea (HU), and filgrastim (granulocyte colony-stimulating factor; G-CSF). 5-FU is administered by 24 hour infusion on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Recombinant alfa-2a interferon is administered subcutaneously immediately before beginning the 5-FU infusion, then three times a week for 6 weeks. HU is administered by 24 hour infusion on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). G-CSF is administered subcutaneously on days 3, 4, 5, and 6 on weeks 1-6. Weeks 7 and 8 are rest periods. Arm II: Patients receive doxorubicin administered by slow IV push followed (30 minutes after infusion) by docetaxel as a 1 hour IV infusion. Treatment is repeated every 21 days. All patients are assessed monthly during study and continue study treatment as long as no disease progression or unacceptable toxic effects are observed. Patients are followed every 3 months for the first 2 years, then every 6 months for years 2-5, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 26 patients (13 in each arm) and a maximum of 80 patients (40 in each arm) will be accrued in this study in approximately 2 years.
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Colorado
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Denver, Colorado, Verenigde Staten, 80209-5031
- CCOP - Colorado Cancer Research Program, Inc.
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, Verenigde Staten, 60611
- Veterans Affairs Medical Center - Chicago (Lakeside)
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Peoria, Illinois, Verenigde Staten, 61602
- CCOP - Illinois Oncology Research Association
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Springfield, Illinois, Verenigde Staten, 62526
- CCOP - Central Illinois
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Iowa
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Cedar Rapids, Iowa, Verenigde Staten, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70121
- CCOP - Ochsner
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- New England Medical Center Hospital
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Michigan
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Kalamazoo, Michigan, Verenigde Staten, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68131
- CCOP - Missouri Valley Cancer Consortium
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New Jersey
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East Orange, New Jersey, Verenigde Staten, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, Verenigde Staten, 07601
- CCOP - Northern New Jersey
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New York
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Bronx, New York, Verenigde Staten, 10461
- Albert Einstein Comprehensive Cancer Center
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester Cancer Center
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- Ireland Cancer Center
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19102-1192
- Allegheny University Hospitals- Hahnemann
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania Cancer Center
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh Cancer Institute
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Wynnewood, Pennsylvania, Verenigde Staten, 19096
- CCOP - MainLine Health
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- Veterans Affairs Medical Center - Madison
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Pretoria, Zuid-Afrika, 0001
- Pretoria Academic Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction beyond the scope of surgical resection Must have measurable disease in either one or two dimensions either radiographically or by physical examination Measurable disease must be documented outside of a prior radiation portal Evaluable disease only not allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No chronic or unstable angina No uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease No seizure disorder No organic mental syndrome No major psychoaffective disorder Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema, sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric illness No active infections, including AIDS, ARC, or HIV positive No history of hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or nursing Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have fully recovered from surgery Other: At least 4 weeks since other investigational agents and recovered from all toxic effects No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- Wadler S, Brain C, Catalano P, Einzig AI, Cella D, Benson AB 3rd. Randomized phase II trial of either fluorouracil, parenteral hydroxyurea, interferon-alpha-2a, and filgrastim or doxorubicin/docetaxel in patients with advanced gastric cancer with quality-of-life assessment: eastern cooperative oncology group study E6296. Cancer J. 2002 May-Jun;8(3):282-6. doi: 10.1097/00130404-200205000-00013.
- Wadler S, Einzig A, Catalano P, et al.: Randomized phase II trial of either flourouracil (F), parenteral hydroxyurea (H), interferon-alfa-2a (I) and filgrastim (G) or doxorubicin/docetaxel (AD) in patients (PTS) with advanced gastric cancer: Eastern Cooperative Oncology Group (ECOG) study EST 6296. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-659, 2001.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antibiotica, antineoplastiek
- Antisikkelmiddelen
- Docetaxel
- Interferonen
- Interferon-alfa
- Fluoruracil
- Doxorubicine
- Liposomale doxorubicine
- Hydroxyureum
Andere studie-ID-nummers
- CDR0000065978
- E-6296
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Maagkanker
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RSP Systems A/SVoltooid
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Medtronic - MITGVoltooid
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State University of New York - Upstate Medical...BeëindigdGastric Bypass-statusVerenigde Staten
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IngetrokkenGastric Bypass-operatie
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Olympus Corporation of the AmericasUnity Health TorontoVoltooid
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidRoux en Y Gastric BypassVerenigde Staten
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North Dakota State UniversityNational Institutes of Health (NIH)VoltooidRoux en Y Gastric Bypass ChirurgieVerenigde Staten
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidSleeve gastrectomie | Roux en Y Gastric BypassVerenigde Staten
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Medical University of South CarolinaVoltooidGastric Bypass Chirurgie PijnbestrijdingVerenigde Staten
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Rijnstate HospitalVoltooid
Klinische onderzoeken op recombinant interferon alfa
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidHersenen en tumoren van het centrale zenuwstelselVerenigde Staten
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Institute of Hematology & Blood Diseases Hospital...WervingEssentiële trombocytopenieChina
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Institute of Hematology & Blood Diseases Hospital...WervingEssentiële trombocytopenieChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidBlaaskanker | Urethrale kankerVerenigde Staten
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The Cleveland ClinicNational Cancer Institute (NCI)VoltooidMelanoma | Sarcoom | Lymfoom | Nierkanker | Borstkanker | Multipel myeloom | Niet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)VoltooidNierkankerVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)BeëindigdBorstkanker | Uitgezaaide kankerVerenigde Staten
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Seoul National University HospitalHanyang UniversityWervingCoronaire hartziekte | Stabiele angina pectoris | Acuut myocardinfarctKorea, republiek van
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Shanghai Jiao Tong University School of MedicineOnbekendNieuwe coronavirusinfectie 2019China
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Fudan UniversityOnbekendHepatocellulair carcinoomChina