NCT00019474

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 13, 2004

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

July 11, 2001

Last Update Submit

September 12, 2018

Conditions

Extrahepatic Bile Duct CancerGastric CancerGastrointestinal Carcinoid TumorLiver CancerPancreatic CancerSmall Intestine Cancer

Keywords

stage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerregional gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancersmall intestine adenocarcinomaunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine canceradult primary hepatocellular carcinomastage IV pancreatic cancer

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
fluorouracilDRUG
hydroxyureaDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Bile Duct NeoplasmsStomach NeoplasmsLiver NeoplasmsPancreatic NeoplasmsCarcinoma, Hepatocellular

Interventions

FilgrastimInterferon-alphaFluorouracilHydroxyurea

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUreaAmidesOrganic Chemicals

Study Officials

  • Scott Wadler, MD

    Albert Einstein College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

April 13, 2004

Study Start

March 1, 1998

Primary Completion

August 1, 2000

Study Completion

August 1, 2000

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

US(1)