Phase II Study of Erlotinib (Tarceva) Alternating With Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer With Molecular Correlates for p53 Pathway
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Response Rates of Radiographically Measurable Disease
研究概览
简要总结
The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must fulfill all of the following criteria to be eligible for study entry:
- •Age 18-80
- •Able to provide informed consent
- •Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum
- •Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer
- •Radiographically measurable disease with at least one bidimensionally measurable lesion of > 1 cm
- •Prior first-line regimen must have been completed at least 4 weeks prior to study treatment
- •Use of biologic agents with first-line chemotherapy permitted
- •Previous adjuvant regimens must have been greater than 6 months before inclusion
- •Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count > 1500/microliter; Hgb > 9 g/dL; platelets > 90,000/microliter; International Normalized Ratio < 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or International Normalized Ratio); bilirubin < 2 times the Upper Limit of Normal; alkaline phosphatase < 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase < 5 times the Upper Limit of Normal; serum creatinine < 1.5 times the Upper Limit of Normal
- •Eastern Cooperative Oncology Group status < 2
排除标准
- •Patients meeting any of the following criteria are ineligible for study entry:
- •Prior second-line chemotherapy regimens for colorectal cancer
- •Prior treatment with erlotinib or gefitinib
- •Central Nervous System metastasis
- •Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed.
- •Untreated/unresolved bowel obstruction
- •Inability to take oral mediations
- •HIV positive
- •Pregnancy
- •Other uncontrolled medical illnesses
- •Current diarrhea > grade 2
- •Symptomatic angina or uncontrolled congestive heart failure
研究组 & 干预措施
FOLFOX with Erlotinib
Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Erlotinib (Drug)
FOLFOX with Erlotinib
Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Fluorouracil (Drug)
FOLFOX with Erlotinib
Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Leucovorin (Drug)
FOLFOX with Erlotinib
Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Oxaliplatin (Drug)
FOLFIRI with Erlotinib
Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Erlotinib (Drug)
FOLFIRI with Erlotinib
Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Fluorouracil (Drug)
FOLFIRI with Erlotinib
Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Leucovorin (Drug)
FOLFIRI with Erlotinib
Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
干预措施: Irinotecan (Drug)
结局指标
主要结局
Response Rates of Radiographically Measurable Disease
时间窗: Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.
The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
次要结局
- Second-line Progression Free Survival(Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.)
- Time to Second Progression (From Start of First-Line Regimen)(Documented by Follow-up CT scans following first line treatment, average of 225 days.)