5-FU Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
First received: August 2, 2012
Last updated: December 17, 2013
Last verified: December 2013
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.
Gastrointestinal Cancer Metastatic
Renal Cell Cancer Metastatic
Non Small Cell Lung Cancer Metastatic
Drug: 5-Fluorouracil and Interferon
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Primary Outcome Measures:
- 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the response rate, median duration of response, and median survival of patients treated with this regimen. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Experimental: 5-Fluorouracil and Interferon
Drug: 5-Fluorouracil and Interferon
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01658813
|Western Regional Medical Center, Inc
|Goodyear, Arizona, United States, 85338 |
Western Regional Medical Center
||Walter Quan, MD
||Western Regional Medical Center, Inc.
No publications provided
||Walter Quan Jr., MD, Chief of Medical Oncology, Western Regional Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2012
||December 17, 2013
||United States: Food and Drug Administration
Keywords provided by Western Regional Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases