Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Carcinoid Tumor; Lung Cancer
Intervention: fluorouracil (Drug); recombinant interferon alfa (Drug); biological therapy (Procedure); chemotherapy (Procedure); cytokine therapy (Procedure); interferon therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Mid-Atlantic Oncology Program Official(s) and/or principal investigator(s):
James D. Ahlgren, MD, Study Chair, Affiliation: George Washington University
Robert K. Oldham, MD, Study Chair, Affiliation: Cancer Therapeutics, Incorporated
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.
Clinical Details
Official title:
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
Study design: Interventional, Treatment
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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
George Washington University Medical Center, Washington, District of Columbia 20037, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: 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. 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.
Last updated: March 5, 2007
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