NCT00069901已完成2 期
CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.
详细描述
CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
- •Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
- •ECOG performance score of 0, 1, or
- •absolute neutrophil count (ANC) at least 1,500/µL.
- •platelet at least 100,000/µL.
- •hemoglobin at least 10 g/dL.
- •creatinine no greater than 1.5 times the upper limit of normal (ULN).
- •bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
- •Alkaline phosphatase no greater than 2.5 x ULN.
排除标准
- •Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
- •Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
- •Synchronous primary endometrial cancer or history of primary endometrial cancer.
- •Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
- •Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
- •Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
- •Prior radiotherapy to any portion of the abdominal cavity or pelvis.
- •Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
- •Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
- •Presence of active hepatitis, either acute or chronic.
- •Presence of active infection requiring antibiotic or antiviral therapy.
- •Pregnant women or nursing mothers.
研究者
研究点 (17)
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