NCT00002470

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 the cancer cells. Combining interferon alfa with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus interferon alfa in treating patients who have advanced metastatic carcinoid tumors.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1990

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1990

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

May 15, 2013

Status Verified

December 1, 2003

First QC Date

November 1, 1999

Last Update Submit

May 14, 2013

Conditions

Gastrointestinal Carcinoid TumorLung Cancer

Keywords

metastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorpulmonary carcinoid tumor

Interventions

recombinant interferon alfaBIOLOGICAL
fluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven carcinoid tumor with radiologically confirmed metastatic disease * Recurrence after surgery or radiotherapy allowed * Must meet at least 1 of the following conditions: * Symptomatic carcinoid syndrome not controlled * Other systemic symptoms (e.g., weight loss, anorexia) * 24 hour urinary 5-hydroxyindole acetic acid (5-HIAA) 100 mg or greater * Bone metastases * Carcinoid heart disease * Carcinoid asthma * Measurable disease or 24-hour urinary 5-HIAA 50 mg or greater required * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 3.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * See Disease Characteristics Pulmonary: * See Disease Characteristics Other: * No concurrent infection (no fever for at least 3 days prior to treatment unless fever due to tumor) * No significant medical or psychiatric illness that would preclude study or informed consent * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or curatively treated stage I carcinoma of the cervix * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon therapy Chemotherapy: * No other concurrent chemotherapy Endocrine therapy: * Prior endocrine therapy allowed * Concurrent octreotide allowed Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * Prior surgery allowed Other: * No prior fluorinated pyrimidine

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

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (2)

  • Ahlgren JD, Leming PD, Gullo JJ, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN) in metastatic carcinoid: updated experience with Mid-Atlantic Oncology Program (MAOP) study 5190. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-552, 219, 1995.

    RESULT

  • Ahlgren JD, Leming PD, Fryer D, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN): a well tolerated regimen for palliation of advanced carcinoid: a Mid-Atlantic Oncology Program (MAOP) study. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-661, 218, 1993.

    RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Interferon-alphaFluorouracil

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • James D. Ahlgren, MD

    George Washington University

    STUDY CHAIR

  • Robert K. Oldham, MD

    Cancer Therapeutics, Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1990

Study Completion

January 1, 2004

Last Updated

May 15, 2013

Record last verified: 2003-12

Locations

US(1)