Clinical trial NCT01658813: 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Cancer Metastatic
Renal Cell Cancer Metastatic
Non Small Cell Lung Cancer Metastatic
Keywords: Metastatic Gastrointestinal
Metastatic Kidney
Metastatic Lung
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Interferon with continuous infusion 5-Fluorouracil (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 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.
* Eastern Cooperative Oncology Group (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 white blood count 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, Aspartate aminotransferase (AST), Alanine aminotransferase (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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Assessed up to 2 years
Secondary outcomes:
measure: Number of Responses
timeFrame: up to 2 years.
measure: Response Rate
timeFrame: up to 2 years
measure: Median Duration of Response
timeFrame: Up tp 2 years
measure: Median Survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc
state: Arizona
Study officials:
affiliation: Western Regional Medical Center, Inc.
name: Walter Quan, MD
role: PRINCIPAL_INVESTIGATOR
References: