Phase 2
Completed N=18
5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Gastrointestinal Cancer Metastatic · Kidney Cancer · Non Small Cell Lung Cancer Metastatic
Source: ClinicalTrials.gov NCT01658813 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Progression Free Survival
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
— | — |
| SECONDARY Number of Responses |
— | — |
| SECONDARY Response Rate |
— | — |
| SECONDARY Median Duration of Response |
— | — |
| SECONDARY Median Survival |
— | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01658813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.