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Phase 2 Completed N=18 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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