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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Carcinoid Tumor, Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James D. Ahlgren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

George Washington University

Authority:

United States: Federal Government

Study ID:

MAOP-5190

NCT ID:

NCT00002470

Start Date:

September 1990

Completion Date:

January 2004

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Lung Cancer
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • pulmonary carcinoid tumor
  • Carcinoid Tumor
  • Lung Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037