5-FU Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
This study is currently recruiting participants.
Verified August 2012 by Western Regional Medical Center
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center, Arizona
First received: August 2, 2012
Last updated: August 28, 2012
Last verified: August 2012
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 2013 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658813
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, Arizona
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2012
||August 28, 2012
||United States: Food and Drug Administration
Keywords provided by Western Regional Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases