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

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002470
• Other study ID #: MAOP-5190
• Secondary ID: CDR0000076667NBS
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 14, 2013
• Start date: September 1990
• Est. completion date: January 2004

Study information

• Verified date: December 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Lung Cancer
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumors

Intervention

Biological:
• recombinant interferon alfa

Drug:
• fluorouracil

Locations

Country	Name	City	State
United States	George Washington University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Mid-Atlantic Oncology Program	Cancer Biotherapy Research Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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