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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

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott Wadler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

September 2004

Related Keywords:

  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • Stomach Neoplasms



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