Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
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.
详细描述
Interferon with continuous infusion 5-Fluorouracil (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
5-Fluorouracil and Interferon
5-Fluorouracil
Interferon-alfa-2b
干预措施: 5-Fluorouracil and Interferon (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Assessed up to 2 years
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.
次要结局
- Number of Responses(up to 2 years.)
- Response Rate(up to 2 years)
- Median Duration of Response(Up tp 2 years)
- Median Survival(up to 2 years)