Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
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
- Efficacy Measured by Response Rate in Participants
研究概览
简要总结
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size
详细描述
This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.
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
- •Histologically or cytologically confirmed recurrent SCCHN
- •18 years or older
- •Tumor site accessible by biopsy
- •Measurable disease
- •Receiving no other therapy
- •ECOG performance status 0-1
- •Adequate bone marrow, renal function and hepatic function
排除标准
- •Active infection or fever within 3 days of treatment
- •Active CNS metastases
- •Prior malignancy within 5 years
- •Hypersensitivity to study drugs
- •Chemotherapy within 30 days of treatment
- •Concurrent investigational therapy within 30 days
- •Radiotherapy of more than 25% of bone marrow
- •Peripheral neuropathy of grade 2 or greater
- •Pregnant or lactating patients
- •History of allogeneic transplant
- •Active or previously treated HIV or Hepatitis B or C
- •Patients with a tracheostomy
研究组 & 干预措施
1
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
干预措施: Oxaliplatin (Drug)
1
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
干预措施: Docetaxel (Drug)
1
Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.
Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Efficacy Measured by Response Rate in Participants
时间窗: 12 Weeks, 1 Year
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
未报告次要终点