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5-FU Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

Information source: Western Regional Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastrointestinal Cancer Metastatic; Renal Cell Cancer Metastatic; Non Small Cell Lung Cancer Metastatic

Intervention: 5-Fluorouracil and Interferon (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Western Regional Medical Center

Official(s) and/or principal investigator(s):
Walter Quan, MD, Principal Investigator, Affiliation: Western Regional Medical Center, Inc.

Summary

The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU) and interferon, which is able to stimulate the immune system to kill cancer cells, will help to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or lung Cancer.

Clinical Details

Official title: Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the progression free survival of patients with metastatic gastrointestinal, kidney, or lung cancer treated with of interferon-alfa-2b and 5-FU who have had disease progression on at least two prior systemic therapies.

Secondary outcome: Determine the response rate, median duration of response, and median survival of patients treated with this regimen.

Detailed description: Interferon with continuous infusion 5-FU regimens have shown response rates ranging from 0-43% in various cancers. Monthly bolus 5-FU + interferon-alfa-2b has not undergone formal phase II testing. In a small pilot study, a 5 consecutive day schedule of 5-FU and interferon-alfa-2b resulted in the limiting toxicities of diarrhea and mucositis. A more limited schedule was recommended. Therefore, it is reasonable to examine such a schedule. In the current study, 5-FU will be followed by interferon-alfa-2b daily for 3 days to attempt to benefit from both the biochemical and immunologic mechanisms described above.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically-proven, metastatic gastrointestinal, kidney, or

lung cancer who have had disease progression on at least two prior systemic therapies.

- ECOG performance status of 0, 1, or 2 and estimated survival of at least 3 months.

- Patients must be felt to have recovered from effects of prior therapy, such as past

expected WBC nadir for chemotherapy (> 2 weeks for most agents, > 6 weeks for nitrosoureas or mitomycin-C)

- Patient consent must be obtained prior to entrance onto study.

- White blood count > 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin >

9. 0 gm/dl; bilirubin, AST, ALT less than 3 times the upper limit of normal; serum creatinine < 1. 8.

- Corticosteroids and immunosuppressive agents are not permitted during the course of

the study. Patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study.

- Patients with elevated temperatures > 100. 5 degrees F, must have sources of occult

infection excluded.

- Women of childbearing potential must have a negative pregnancy test and must take

adequate precautions to prevent pregnancy during treatment. Exclusion Criteria:

- Evidence of significant cardiovascular disease including history of recent (< 6

months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, or cerebrovascular accident.

- Prior history of psychiatric disorder that could be exacerbated by interferon therapy

or which could preclude completion of this therapy.

- Pregnancy or lactation.

- History of hypersensitivity to interferon alfa or fluoropyrimidines.

- History of severe debilitating pulmonary disease, such as chronic obstructive

pulmonary disease requiring continuous oxygen therapy.

- History of autoimmune disease requiring immunosuppression.

- Documented inflammatory joint or systemic inflammatory disease (such as Lupus) which

could be exacerbated by interferon therapy.

Locations and Contacts

Western Regional Medical Center, Inc, Goodyear, Arizona 85338, United States
Additional Information

Starting date: July 2012
Last updated: June 1, 2015

Page last updated: August 20, 2015

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