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Phase II Trial of 2-Fluorouracil Recombinant Alpha-2a-Interferon and Intravenous Hydroxyurea With Filigrastim in Patients With Refractory GI Malignancies Grant Application Title: Parenteral Hydroxyurea: A Modulator in Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Liver Cancer, Pancreatic Cancer, Small Intestine Cancer

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Trial Information

Phase II Trial of 2-Fluorouracil Recombinant Alpha-2a-Interferon and Intravenous Hydroxyurea With Filigrastim in Patients With Refractory GI Malignancies Grant Application Title: Parenteral Hydroxyurea: A Modulator in Pancreatic Cancer

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

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.

Inclusion 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

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

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)

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:

March 1998

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Liver Cancer
  • Pancreatic Cancer
  • Small Intestine Cancer
  • 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
  • Carcinoid Tumor
  • Liver Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Bile Duct Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461