Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
Condition: Extrahepatic Bile Duct Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Liver Cancer; Pancreatic Cancer; Small Intestine Cancer
MeSH terms: Pancreatic Neoplasms; Stomach Neoplasms; Liver Neoplasms; Carcinoid Tumor; Bile Duct Neoplasms; Cholangiocarcinoma; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Intestinal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.

      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.
    

Intervention name(s): filgrastim; recombinant interferon alfa; fluorouracil; hydroxyurea
Intervention type(s): Biological; Biological; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Fluorouracil; Hydroxyurea
Primary purpose: Treatment
Keywords: stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; regional gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; small intestine adenocarcinoma; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; adult primary hepatocellular carcinoma; stage IV pancreatic cancer