Clinical trial · Interventional
5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
NCT01658813CI-TRIAL-00032160completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer Metastatic | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil and Interferon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-Fluorouracil and Interferon
- description
- 5-Fluorouracil Interferon-alfa-2b
- interventionNames
- Drug: 5-Fluorouracil and Interferon
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Assessed up to 2 years
- description
- Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors \[RECIST\] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.