Combination Chemotherapy Followed by Surgery and Intraperitoneal Chemotherapy in Treating Patients With Locally Advanced Stomach Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00006038
First received: July 5, 2000
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: cisplatin
Drug: docetaxel
Drug: floxuridine
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: February 2000
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006038

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David Paul Kelsen, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006038     History of Changes
Other Study ID Numbers: 99-066, CDR0000068053, NCI-G00-1813
Study First Received: July 5, 2000
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Floxuridine
Fluorouracil
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on July 20, 2014