Combination Chemotherapy Followed by Surgery and Intraperitoneal Chemotherapy in Treating Patients With Locally Advanced Stomach Cancer
A Phase II Trial of Neoadjuvant Cisplatin-Fluorouracil-Docetaxel Chemotherapy, Surgery, and Intraperitoneal (IP) Floxuridine (FUdR) Plus Leucovorin in Patients With Locally Advanced Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
OBJECTIVES: I. Determine the efficacy and toxicity of neoadjuvant cisplatin, fluorouracil, and docetaxel, and postoperative intraperitoneal floxuridine and leucovorin calcium in patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction. II. Determine whether molecular markers, including thymidylate synthase, excision repair cross complementing gene, and tubulin isoform 4B, for sensitivity to fluorouracil, cisplatin, and docetaxel, respectively, are predictive of outcome (disease free survival and overall survival) in these patients. III. Determine the quality of life of these patients treated with this regimen.
OUTLINE: During weeks 1 and 4, patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1, and fluorouracil IV continuously on days 1-5. During weeks 6-8, patients undergo radical subtotal or total gastrectomy with a D2 lymph node dissection followed by percutaneous placement of an intraperitoneal port device. Beginning within 5 days after resection, patients with clear margins receive floxuridine and leucovorin calcium intraperitoneally on days 1-3 during weeks 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to beginning study, prior to surgery, then monthly for 3 months beginning after completion of study therapy, then every 3 months through year 2, and then every 6 months through year 3. Patients are followed monthly for 3 months, then every 3 months through year 2, and then every 6 months though year 3.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.5 years.
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS: Histologically proven locally advanced adenocarcinoma of the stomach or gastroesophageal (GE) junction that is potentially curable by surgery Patients with tumors involving the GE junction must have the bulk of their disease in the stomach No tumors of the distal esophagus or GE junction that extend less than 2 cm into the stomach Tumor stage T2, N1-2, M0 OR T3-4, any N, M0 by physical exam, CT scan, and laparoscopy
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 2 mg/dL SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN Ineligible if SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN Renal: Blood urea nitrogen no greater than 30 mg/dL Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No active angina or myocardial infarction within the past 6 months No history of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality Other: No clinically significant auditory impairment No worse than grade 2 preexisting peripheral neuropathy No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy No psychiatric disorder that would preclude compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
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
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Maagneoplasmata
- Slokdarmneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Beschermende middelen
- Micronutriënten
- Vitaminen
- Calciumregulerende hormonen en middelen
- Tegengif
- Vitamine B-complex
- Docetaxel
- Fluoruracil
- Leucovorin
- Calcium
- Levoleucovorine
- Floxuridine
Andere studie-ID-nummers
- 99-066
- CDR0000068053 (Register-ID: PDQ (Physician Data Query))
- NCI-G00-1813
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