NCT00165490已完成2 期
Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.
详细描述
- Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
- Outpatient therapy with cetuximab alone will be given intravenously on week 0.
- During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
- Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
- A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
- Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
- Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
- During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
- Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
- After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.
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
- •18 years of age or older
- •Negative pregnancy test
- •Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
- •ECOG performance status of 0 or
- •Neutrophils greater or equal to 1,500/ul
- •Platelets greater or equal to 100,000/ul
- •Serum bilirubin less or equal to 1.5mg/ul
- •Serum creatinine less or equal to 1.5mg/ul
- •AST or SGOT less or equal to 2.5x upper normal limit
- •Alkaline phosphatase less or equal to 5x upper normal limit
排除标准
- •Prior surgery for esophageal or gastro-esophageal junction cancer.
- •Prior chemotherapy or radiation therapy
- •Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
- •Metastatic disease to distant organs or non-regional lymph nodes.
- •Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
- •Pregnant or lactating women
- •Other active malignancy
- •Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
- •History of seizure disorder
- •Uncontrolled diarrhea
- •Peripheral neuropathy (Grade 2)
- •Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
结局指标
主要结局
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
时间窗: 3 years
次要结局
- To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.
- To determine the safety of the drug combination and radiation therapy(3 years)
研究者
Peter C. Enzinger, MD
Overall PI
Dana-Farber Cancer Institute
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
2 期
Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic CarcinomaThymic CarcinomaClinical Masaoka Stage II to IVAThymomaNCT01025089Memorial Sloan Kettering Cancer Center18
已完成
2 期
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung CancerExtensive Stage Small Cell Lung CancerNCT00118235National Cancer Institute (NCI)72
已完成
2 期
Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell CancerMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySalivary Gland Squamous Cell CarcinomaStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityUntreated Metastatic Squamous Neck Cancer With Occult PrimaryTongue CancerNCT01316757Fox Chase Cancer Center24
已完成
3 期
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00622349European Lung Cancer Working Party707
已完成
2 期
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)Head and Neck NeoplasmNCT00623558Seoul National University Hospital92