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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019474
  Purpose

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 Intervention Phase
Extrahepatic Bile Duct Cancer
Gastric Cancer
Gastrointestinal Carcinoid Tumor
Liver Cancer
Pancreatic Cancer
Small Intestine Cancer
Drug: filgrastim
Drug: fluorouracil
Drug: hydroxyurea
Drug: recombinant interferon alfa
Phase II

MedlinePlus related topics:   Cancer    Carcinoid Tumors    Intestinal Cancer    Liver Cancer    Pancreatic Cancer    Stomach Cancer   

ChemIDplus related topics:   Filgrastim    Hydroxyurea    Fluorouracil    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   60
Study Start Date:   March 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019474

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

Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)

Investigators
Study Chair:     Scott Wadler, MD     Albert Einstein College of Medicine of Yeshiva University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066253, AECM-9707254, MMC-9007262-PHII, MMC-FDR001009-PHII
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00019474
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Interferon Type I, Recombinant
Liver Diseases
Hydroxyurea
Carcinoma, Hepatocellular
Gastrointestinal Diseases
Pancreatic Neoplasms
Liver neoplasms
Duodenal Neoplasms
Liver Neoplasms
Stomach Diseases
Ileal Neoplasms
Biliary Tract Diseases
Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Duodenal Diseases
Hepatocellular carcinoma
Endocrine Gland Neoplasms
Interferon-alpha
Bile duct cancer, extrahepatic
Jejunal Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Interferons
Serotonin Syndrome
Endocrine System Diseases
Stomach cancer
Malignant Carcinoid Syndrome
Intestinal Diseases
Carcinoid syndrome

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Hematologic Agents
Ileal Diseases
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antisickling Agents
Growth Substances
Enzyme Inhibitors
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on October 06, 2008




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