Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Number of Participants With and Without Hypersensitivity Reaction
研究概览
简要总结
Patients who have this kind of cancer are often treated with several drugs. Carboplatin is one that seems to work for many treatment cycles. Even though it may work against the cancer, the patient can become allergic to it. If that happens, they would have to stop taking the drug. The standard way to give carboplatin is by vein over 30 minutes. Some people have been given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected.
The purpose of this study is to:
Find out if giving carboplatin over three hours can prevent the allergy.
See if medicine given before the carboplatin can help reduce the risk of allergic reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma.
- •Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
- •Age ≥ 21 years old
- •Karnofsky Performance Status (KPS) > or = to 70%
- •Adequate hematologic, hepatic and renal function as defined below:
- •Hemoglobin ≥ 7.0 g/dl
- •Absolute neutrophil count ≥ 1,000/mm3
- •Platelet count ≥ 100,000/mm3
- •Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min
排除标准
- •Prior carboplatin or cisplatin hypersensitivity reaction
- •Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.
- •Patients receiving other investigational agents
- •Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months
- •Pregnant or lactating women
- •Life expectancy of less than 12 weeks
研究组 & 干预措施
Standard 30-minute infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
干预措施: carboplatin (Drug)
extended 3-hour infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
干预措施: carboplatin (Drug)
结局指标
主要结局
Number of Participants With and Without Hypersensitivity Reaction
时间窗: 2 years
The primary objective of this study is to determine if patients have lower rates of hypersensitivity reactions by comparing the number of participants with and without hypersensitivity reaction
次要结局
- The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate(2 years)
- Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.(2 years)
- The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group(2 years)