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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


Phase 2
N/A
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-066

NCT ID:

NCT00006038

Start Date:

February 2000

Completion Date:

February 2003

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021