A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 12
- 主要终点
- Objective Response
研究概览
简要总结
The purpose of this study is to determine whether panitumumab in combination with capecitabine/oxaliplatin are effective as first-line treatment in wild-type k-ras, metastatic colorectal cancer patients.
详细描述
This is a single-arm trial in which previously untreated, wild-type k-ras metastatic colorectal cancer patients will receive therapy with the combination of panitumumab with capecitabine and oxaliplatin. During the treatment period of 6 cycles, subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent. Those patients with disease stabilization who are not appropriate for chemotherapy may continue with panitumumab alone. Patients with disease progression will be discontinued from chemotherapy and panitumumab and will be followed every 3 months after the last drug administration until death. Tumor response will be assessed according to the RECIST criteria (investigator's read of scans), every 6 weeks through week 18 and every 3 months thereafter, until disease progression. Disease progression will also be evaluated radiographically at the time of clinical suspicion of progression.
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
- •Ability to comprehend and sign an informed consent
- •Aged 18 years or more
- •Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum
- •Measurable disease according to the RECIST criteria
- •Eastern Cooperative Oncology Group (ECOG) status of 0-2
- •Non-mutated k-ras gene (k-ras status will be assessed by DNA sequencing in codons 12 and 13)
- •Haematologic function: ANC >1.5 x 109/L, Leucocyte count >3000/mm3, Haemoglobin >10g/ d L, PLT >100 x 109/ L
- •Renal function: serum creatinine ≤1.5xUNL or creatinine clearance > 50ml/min
- •Hepatic function:
- •Total bilirubin ≤ 1.5 time the upper normal limit (UNL)
- •ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases
- •ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases
- •Metabolic function:
- •Magnesium ≥ lower limit of normal.
- •Calcium ≥ lower limit of normal.
排除标准
- •Central nervous system metastases
- •Prior therapy for metastatic disease
- •Adjuvant chemotherapy for the last 6 months
- •Prior anti-EGFR therapy or treatment with EGFR tyrosine kinase inhibitors
- •Prior radiotherapy within 30 days from enrollment
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Inflammatory bowel disease or chronic diarrhea
- •Dihydropyrimidine deficiency
- •Positive test for HIV infection, hepatitis C infection, chronic active hepatitis B infection
- •Any kind of disorder compromising the ability of the patient to give informed consent
- •Any investigational agent within 30 days prior to initiation of the study
- •Any surgical procedure within 28 days prior to initiation of the study
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Female subject in childbearing age with a positive pregnancy test at screening or before initiation of study treatment.
- •Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
研究组 & 干预措施
Panitumumab,capecitabine,oxaliplatin
Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg.
Oxaliplatin 130 mg/m2 IV infusion over 2 hours on Day 1 Capecitabine 2000 mg/m2 divided in two doses, orally, on Days 1 - 14
干预措施: panitumumab (Drug)
结局指标
主要结局
Objective Response
时间窗: Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Response will be evaluated using the RECIST criteria. Response rates will be presented as counts and proportions along with 95% exact confidence intervals. An Objective Response is defined as either a Complete Response or a Partial Response. Analysis will be performed in the intent-to-treat population, i.e. all eligible patients enrolled in the study.
次要结局
- Overall Survival (OS)(24 months)
- Progression-Free Survival(PFS)(Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.)
- Adverse Events (AE)of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.(18 months)
- Economic evaluation(18 months)