Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Patients With Carboplatin Reactions of Different Severity
研究概览
简要总结
This is a research study to determine if administering carboplatin at a slower rate when re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity reaction will decrease the frequency and severity of future hypersensitivity reactions.
详细描述
For women with recurrent ovarian cancer, re-treatment with carboplatin is frequently recommended. However, carboplatin re-treatment can result in an allergic or allergic-like reaction called a hypersensitivity reaction. Symptoms of a hypersensitivity reaction can include, but are not limited to itching, rash, swelling of the lips, tongue, or throat, chest pain, chest tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting, diarrhea, palpitations, dizziness, confusion, and low pressure. Hypersensitivity reactions occur in 20-40% of women with recurrent ovarian cancer who are re-treated with carboplatin. At least half of the hypersensitivity reactions are described as moderately severe with symptoms of generalized rash, wheezing, facial swelling, difficulty breathing/shortness of breath, and hypotension (low blood pressure).
Patients who suffer from a hypersensitivity reaction while receiving carboplatin and require additional therapy may receive future carboplatin infusions utilizing a "desensitization" technique. A desensitization is when carboplatin is administered in slowly increasing amounts as an inpatient under the direction of the department of Allergy Immunology at Massachusetts General Hospital. A desensitization allows patient to safely receive carboplatin, but requires an inpatient hospitalization, which may be of significant inconvenience to some patients.
As part of this study, the participant will continue to receive carboplatin as part of their standard therapy. The change would be instead of carboplatin being administered over a 30 minute period, the carboplatin be administered intravenously according to the following schedule:
- First hour - Administer 1 percent of total dose
- Second hour - Administer 9 percent
- Third hour - Administer 90 percent
Standard pre-medications will be administered immediately prior to the carboplatin infusion which will include of 20 mg of dexamethasone, 50mg of diphenhydramine, and famotidine 20 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participants must have histologically or cytologically confirmed ovarian cancers for which carboplatin is an acceptable treatment option. In addition, participants must be candidates for systemic chemotherapy as determined by their treating physician.
- •Participants must have received a carboplatin-containing regimen at initial diagnosis. Retreatment is permitted in second or greater line with carboplatin-based chemotherapy.
- •Age ≥ 18 years of age
- •Eastern Cooperative Oncology Group performance status <2 (see Appendix A).
- •Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating chemotherapy on trial and must agree to practice an effective method of birth control, such as an intrauterine device, tubal ligation, or oral contraceptives, during the study and for six months after their last treatment. Women should not breast-feed while on this study
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients must be willing to comply with study design and requirements for participating on the study.
- •Laboratory Criteria for eligibility The following are laboratory criteria for baseline absolute neutrophil count, platelet count, and creatinine for inclusion on this study.
排除标准
- •Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Carboplatin
Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:
- First hour - Administer 1 percent of total dose (5ml with tubing primed)
- Second hour - Administer 9 percent (45 mL)
- Third hour - Administer 90 percent (450 mL)
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of Patients With Carboplatin Reactions of Different Severity
时间窗: 2 Years
To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program
时间窗: 2 Years
To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program
次要结局
未报告次要终点
研究者
Aleena Banerji
Principal Investigator
Massachusetts General Hospital