RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person recover from the side effects of chemotherapy. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and interferon alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer.

Condition	Treatment or Intervention	Phase
Pancreatic Cancer Gastric Cancer adult primary liver cancer	Drug: filgrastim  Drug: fluorouracil  Drug: hydroxyurea  Drug: interferon alfa	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response rates in patients with unresectable locally advanced or advanced gastrointestinal malignancy treated with intravenous hydroxyurea, fluorouracil, interferon alfa, and filgrastim (G-CSF). II. Determine the toxic effects of this regimen in these patients. III. Determine the reversal of toxic effects of this regimen in these patients.

PROTOCOL OUTLINE: Patients are stratified according to site of primary disease (hepatobiliary vs gastric vs pancreatic). Patients receive fluorouracil IV over 48 hours and hydroxyurea IV over 48 hours on days 1, 8, 22, and 29. Patients also receive interferon alfa subcutaneously (SC) on days 1, 3, and 5 and filgrastim (G-CSF) SC on days 3-6 of weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 31-60 patients (18-33 with hepatobiliary or gastric cancer and 13-27 with pancreatic cancer) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed pancreatic, gastric, biliary system, or hepatocellular carcinoma beyond the scope of surgical resection
• Gastrointestinal tract carcinoid tumor or carcinoma of the small bowel allowed
• Bidimensionally measurable disease
• Ineligible for ECOG 6296 (gastric cancer)
• No brain metastases, unless completely resected and CT scan of the brain is normal

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent immunotherapy
• Chemotherapy: No prior systemic chemotherapy for advanced disease; Prior fluorouracil or gemcitabine as radiosensitizer allowed; No other prior chemotherapy
• Endocrine therapy: No concurrent systemic steroids; No concurrent hormonal therapy (excluding birth control pills); No concurrent steroids as antiemetics or for chronic treatment
• Radiotherapy: At least 1 month since prior radiotherapy
• Surgery: See Disease Characteristics; Recovered from prior surgery
• Other: At least 1 week since prior beta blockers; No concurrent chronic treatment with aspirin, non-steroidal anti-inflammatory drugs, antihistamines, antianginal medication, extraordinary antihypertensive regimens, or antiarrhythmics (except cardiac glycosides)

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 3 times normal; SGOT less than 3 times normal
• Renal: Creatinine no greater than 2.0 mg/dL
• Cardiovascular: No New York Heart Association class III or IV heart disease; No chronic or uncontrolled angina; No significant coronary artery disease (even if asymptomatic) on cardiac catheterization or thallium stress test, in patients with a history of atherosclerotic heart disease; No congestive heart failure; No arrhythmia
• Pulmonary: No chronic obstructive pulmonary disease; No chronic pulmonary disease, including asthma, chronic bronchitis, emphysema, sarcoid, or bronchiectasis
• Neurologic: No cerebellar disease; No seizure disorder
• Other: HIV negative; No active or serious underlying infection; No AIDS; No psychiatric illness; No organic mental syndrome; No major psychoaffective disorder; No poorly controlled diabetes mellitus; No serious underlying illness that would preclude study; No recent history of alcohol or drug abuse; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

Study chairs or principal investigators

Scott Wadler,  Study Chair,  Albert Einstein Cancer Research Center   

Study ID Numbers:  CDR0000066253; AECM-9707254; MMC-9007262-PHII; MMC-FDR001009-PHII
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00019474
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08