Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 17
- 主要终点
- Occurrence of grade 4 neutropenia
研究概览
简要总结
Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly paclitaxel/carboplatin regimen in gynaecological cancers.
Purpose: This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma. Data obtained in this trial will be compared with historical data as published earlier.
The trial will include 3 cohorts of 36 patients:
- Subjects with ovarian, fallopian tube or peritoneal carcinoma
- Subjects with endometrial cancer
- Subjects with cervical carcinoma
Treatment:
Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2 years and then if clinically indicated. Subjects who develop disease progression will discontinue therapy. Subjects who have no evidence of disease progression after completion of study therapy will be followed until disease progression, withdrawal of informed consent, or death.
详细描述
Primary objective:
- To evaluate the occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF
Secondary objectives:
- To evaluate per cohort the occurrence of grade 4 neutropenia
- To evaluate other toxicities
- To evaluate the dose reductions or dose delays in the chemotherapy
- To determine the progression free survival according to RECIST v1.1
- To evaluate the response rate and overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •All cohorts:
- •Female subjects more than 18 years of age
- •Performance status must be ECOG 0-
- •Adequate organ function
- •Measurable disease by RECIST version 1.1 or CA125 progression according to the GCIG definition (Vergote et al).
- •Written informed consent
- •Ovarian, fallopian tube or peritoneal carcinoma cohort:
- •Histologically confirmed diagnosis of invasive epithelial ovarian,fallopian tube, or peritoneal carcinoma (serous, mucinous, endometrioid,clear cell, or carcinosarcomas are eligible).
- •Patients should have received at least 1 earlier platin treatment but should be platin refractory (progression within 28 days after the last dose of platin) or platin resistant (progression within 6 months after last dose of platin therapy).
- •Earlier weekly or dose-dense regimens with paclitaxel and carboplatin are not allowed. Consolidation after the last platin dose with non-platinum containing chemotherapy or molecular targeted drugs is allowed
- •Endometrial carcinoma cohort
- •Histologically confirmed diagnosis of endometrial carcinoma (endometrioid,adenoacanthoma, adenosquamous, serous, clear cell carcinoma or carcinosarcomas are eligible).
- •Recurrent or advanced endometrial carcinoma can be included.
- •Earlier platin therapy is allowed. But earlier weekly or dose-dense regimens with paclitaxel and carboplatin are not allowed.
- •Cervical carcinoma cohort
- •Histologically confirmed diagnosis of cervical carcinoma (adenocarcinoma or squamous carcinomas are eligible).
- •Recurrent or advanced endometrial carcinoma can be included.
- •Earlier platin (including concomitant with radiotherapy) therapy is allowed. But earlier weekly or dose-dense regimens with paclitaxel and carboplatin are not allowed.
排除标准
- •Other histologies than those mentioned above such as non-epithelial ovarian carcinomas, neuro-endocrine tumors, sarcomas, metastases from other primary tumors, ...
- •Earlier weekly or dose-dense paclitaxel and carboplatin regimen.
- •Any unstable or serious condition e.g. uncontrolled infection requiring systemic therapy.
- •Prior other malignancies treated primarily or for recurrence within 3 years prior to inclusion in this study, except for completely resected non- melanomatous skin carcinoma or successfully treated in situ carcinoma of the skin or cervix of the uterus.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- •Metastatic disease to the brain or leptomeninges.
- •Treatment with any of the following anti-cancer therapies:
- •radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of study chemotherapy.
- •chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs similar or related to Paclitaxel, Carboplatin or G-CSF.
研究组 & 干预措施
Filgrastim
干预措施: Filgrastim (Drug)
Filgrastim
干预措施: Paclitaxel (Drug)
Filgrastim
干预措施: Carboplatin (Drug)
结局指标
主要结局
Occurrence of grade 4 neutropenia
时间窗: 2.5 years
次要结局
- Occurence of other toxicities(2.5 years)
- Overall survival(3 years, 7 years)
- Progression free survival(3 years, 7 years)
- Occurence of dose reductions and dose delays(2.5 years)