Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Best Response (BR)
研究概览
简要总结
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Metastatic colorectal cancer, histologically or cytologically confirmed
- •Age 18 or greater
- •Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count > 100,000)
- •Adequate hepatic parameters (bilirubin < 2.0, Alk. Phos < 5 times normal, ALT < 5 times normal)
- •Adequate renal function (creatinine < 2.0)
- •Performance status ECOG 0-2
- •0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
- •Absence of other serious concurrent medical illnesses
- •Evaluable or measurable disease for phase I; measurable disease only for phase II
排除标准
- •Histologies other than adenocarcinoma
- •Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
- •Uncontrolled brain metastases
- •Chronic diarrhea (greater than five bowel movements per day)
- •Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
- •Major surgery within 2 weeks before study entry
- •Known allergic sensitivity to leucovorin
- •Prior exposure to IFN-γ
- •Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
- •Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
- •Inability to provide written and informed consent
- •Uncontrolled hypertension
- •History of deep venous thrombosis or CVA
- •Prior exposure to bevacizumab
- •Proteinuria > 500 mg/24 hr
研究组 & 干预措施
Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
干预措施: 5-Fluorouracil (Drug)
Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
干预措施: Leucovorin (LV) (Drug)
Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
干预措施: Gamma-Interferon-1b (IFN-γ) (Drug)
Stratum 1
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
干预措施: Bevacizumab (Drug)
Stratum 2
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
干预措施: 5-Fluorouracil (Drug)
Stratum 2
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
干预措施: Leucovorin (LV) (Drug)
Stratum 2
Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
干预措施: Gamma-Interferon-1b (IFN-γ) (Drug)
结局指标
主要结局
Best Response (BR)
时间窗: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; PD, increase in existing lesions or new lesions.
次要结局
- Early Response Rate (RR) (Stratum 1 Only)(After 4 cycles of treatment (approximately 56 days))
- Time to Progression(From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months)