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Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors

Primary Purpose

Gastrointestinal Carcinoid Tumor, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
fluorouracil
Sponsored by
Mid-Atlantic Oncology Program
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • George Washington University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 14, 2013
Sponsor
Mid-Atlantic Oncology Program
Collaborators
Cancer Biotherapy Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002470
Brief Title
Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
Official Title
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
September 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mid-Atlantic Oncology Program
Collaborators
Cancer Biotherapy Research Group

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the objective response rate and duration of remission in patients with advanced metastatic carcinoid tumors treated with fluorouracil and interferon alfa-2b. Determine the symptomatic response in patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the quality of life of patients treated with this regimen. Determine the survival characteristics of patients treated with this regimen. OUTLINE: Patients receive fluorouracil IV continuously for 10 weeks and interferon alfa subcutaneously 3 times a week for 12 weeks. Treatment continues every 12 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 1, 7, and 11 of each course. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Carcinoid Tumor, Lung Cancer
Keywords
metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, pulmonary carcinoid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
fluorouracil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Ahlgren, MD
Organizational Affiliation
George Washington University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert K. Oldham, MD
Organizational Affiliation
Cancer Therapeutics, Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors

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