KCT0004314招募中未知
Phase 2 study of paclitaxel plus anti-EGFR as a second-line therapy for gastric and gastroesophageal junction adenocarcinomas
ational Cancer Center0 个研究点目标入组 44 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •Part 1. EGFR
- •1. Pathologically or cytologically proven gastric adenocarcinoma
- •2. 18 years of age or older on the date of signing the consent form
- •3. Patients with ECOG performance status 0-2
- •4. Patients with expected survival > 12 weeks
- •5. A person whose appropriate organ function is identified as defined in the section below:
- •- Hemoglobin = 9.0 g/dL
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L (= 1,500 per mm3)
- •- Platelet count = 100 x 109/L (= 100,000 per mm3)
- •- Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (excluding Gilbert ’s syndrome)
- •- AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL: if there is liver metastasis = 5x ULN
- •- 24-h urine creatinine clearance or eGFR > 40 mL/min
- •6. For women, a pregnancy test is negative or non-fertile women as defined below:
- •- History of menopause (discontinuation of menstruation for more than 1 year without other medical reasons)
- •- Patients who underwent hysterectomy, bilateral ligation or bilateral ovarian resection
- •7. Patients willing to comply with scheduled treatment and follow-up schedules
- •8. EGFR focal amplification or EGFR immunostaining positive (3+) as a result of targeted sequencing. For targeted sequencing, amplification is defined as the case of copy number (CN) = 4 in cancer sequencing results, as described in detail in 6. Screening Section of Page 24 of the Plan (not applicable to the safety run-in group).
- •For patients whose simultaneous gene amplification of ERBB2 and EGFR are found, targeted therapy with ERBB2 should be prioritized in this trial.
- •9. Presence of measurable lesions on RECIST (not applicable to the safety run-in group)
- •10. Progression of disease after the administration of one type of anticancer drug in the treatment of metastatic gastric cancer, or progression of the disease during or within 6 months of the termination (as of the last chemotherapy date) of anticancer drug administration used as adjuvant chemotherapy;
- •(However, in the case of the safety run-in group, it is a rule to target disease progression after the administration of two or more anticancer drugs in the treatment of metastatic gastric cancer. If there is EGFR gene amplification or overexpression as described in # 8 above, disease progression after the administration of one anticancer agent can be listed.)
排除标准
- •Part 1. EGFR
- •1. Patients with a history of allergies to taxane drugs
- •2. As of the first day of administration of the study drug, subjects who did not take 2 weeks after systemic chemotherapies (including immunotherapy and small molecule target therapy), who did not take 4 weeks after the administration of a monoclonal antibody or who did not take 6 weeks after the administration of nitrosourea/mitomycin C
- •3. History of primary cancers other than gastric cancer
- •except for the following cases:
- •- Patients who have been disease-free for more than 3 years since curative treatment of cancer and have a low risk of recurrence
- •- Patients currently free of non-melanoma skin cancer (lentigo maligna)
- •- Patient currently free of disease in situ carcinoma
- •4. In some circumstances, treatment or history, in which the investigator's judgment of the subject indicates that evaluation of the clinical trial results will be difficult
- •5. History of treatment with EGFR monoclonal antibodies or taxanes as a first-line therapy for metastatic gastric cancer
- •6. Uncontrolled active infections, symptomatic heart failure, uncontrolled hypertension/unstable angina/arrhythmia, active bleeding tendency, active hepatitis, mental illness or social conditions that interfere with written consent
- •7. Patients with a history of leptomeningeal metastasis.
- •8. Patients with uncontrolled symptoms of brain metastases or spinal neuralgia (patients whose symptoms have stabilized with steroids and anticonvulsants removed at least 14 days prior to the administration of the study drug are allowed)
- •9. Patients with uncontrolled seizures
- •10. Pregnant or lactating women, women of childbearing potential, or men who are not willing to use appropriate contraception within 180 days of study termination
研究者
相似试验
招募中
2 期
Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancerbreast cancerJPRN-UMIN000006428Toho University Omori Medical Center40
招募中
2 期
Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast CancerBreast cancerJPRN-UMIN000009152Toho University Omori Medical Center40
已完成
2 期
A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimenon-small cell lung cancerJPRN-C000000219West Japan Oncology Group80
未知
2 期
Phase II study of a combined Paclitaxel, Gemcitabine, and Cisplatin chemotherapy regimen for advanced urothelial carcinomaadvanced urothelial carcinomaJPRN-UMIN000001979Cancer Institute Hospital, Japanese Foundation for Cancer Research30
招募中
2 期
Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric CancerAdvanced or recurrent gastric cancer previously treated with S-1JPRN-UMIN000008632Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine35