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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer  Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
For Condition: Pancreatic Cancer,adult primary liver cancer,Gastric Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Albert Einstein Cancer Research Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottWadler, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000066253; MMC-9007262-PHII,AECM-9707254,MMC-FDR001009-PHII
Study Start Date: March 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019474
Other Adult Primary Liver Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
3. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
4. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
5. Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
Related Studies:
Other adult primary liver cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Combination Chemotherapy Plus Interferon Alfa Followed by Filgrastim in Treating Patients With Gastrointestinal Tract Cancer
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