A Phase I Trial of Dose Dense (Biweekly) Carboplatin Combined With Paclitaxel and Pegfilgrastim (Neulasta): A Feasibility Study in Patients With Untreated Stage III and IV Ovarian, Tubal or Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 11
- 主要终点
- Number of patients who have greater than or equal to 1 dose-limiting toxicity, assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
研究概览
简要总结
This phase I trial is studying the side effects of giving carboplatin and paclitaxel together with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial, fallopian tube, primary peritoneal, or carcinosarcoma cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may kill any tumor cells that remain after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by pegfilgrastim, in terms of absence of grade 3 or 4 nonhematologic toxicities without major dose delays or additional hematological support (e.g., red blood cell or platelet transfusions or admission for febrile neutropenia), in patients with stage III-IV ovarian epithelial, fallopian tube, primary peritoneal cancer, or carcinosarcoma cancer.
SECONDARY OBJECTIVES:
I. Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
II. Estimate the clinical response rate in patients with measurable disease treated with this regimen.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of 1 of the following:
- •Primary peritoneal carcinoma
- •Fallopian tube carcinoma
- •Ovarian epithelial carcinoma
- •Carcinosarcoma
- •Stage III or IV disease
- •Previously untreated disease, except for mandatory prior surgery
- •No ovarian epithelial carcinoma of low malignant potential (i.e., borderline carcinomas)
- •GOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0 g/dL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •SGOT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •No peripheral neuropathy (sensory or motor) ≥ grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
- •No septicemia, severe infection, or acute hepatitis
- •No prior radiotherapy or chemotherapy
- •No prior cancer treatment that would contraindicate study treatment
排除标准
- 未提供
研究组 & 干预措施
Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
干预措施: Adjuvant Therapy (Procedure)
Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
干预措施: Carboplatin (Drug)
Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
干预措施: Paclitaxel (Drug)
Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
干预措施: Pegfilgrastim (Biological)
结局指标
主要结局
Number of patients who have greater than or equal to 1 dose-limiting toxicity, assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
时间窗: 12 weeks
次要结局
- Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale(Up to 1 year)
- Grade of toxicity as assessed by CTCAE v3.0(Up to 1 year)
- Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)(Up to 1 year)