Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer

September 12, 2018 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 contraception

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (ACTUAL)

August 1, 2000

Study Completion (ACTUAL)

August 1, 2000

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

April 12, 2004

First Posted (ESTIMATE)

April 13, 2004

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066253
  • P30CA013330 (U.S. NIH Grant/Contract)
  • AECM-9707254
  • MMC-9007262-PHII
  • MMC-FDR001009-PHII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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