A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Complete Response Rate
研究概览
简要总结
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.
详细描述
Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to efficacy; when evaluating cost and convenience, the intravenous route may be preferable. Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant via phosphatases following intravenous administration. Given the rapid conversion of fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a similarly effective antiemetic impact. Clinical reports have additionally suggested that fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.
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
- Double (Participant, Investigator)
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
- •Female Gender
- •Age > 18 years
- •A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian, fallopian tube, peritoneal cancer and uterine cancer).
- •Subjects who will be treated with Taxol and Carboplatin as standard of care for a newly diagnosed gynecological cancer.
- •Adequate bone marrow function as demonstrated by:
- •Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9 g/dL • Adequate renal function demonstrated by: Serum creatinine of < 1.5 x ULN or 24-hr measured urine creatinine clearance > 60 mL/min for patients with serum creatinine > 1.5 x ULN
- •Adequate hepatic function demonstrated by: Total bilirubin of < 1.5 x ULN AST or ALT ≤ 2.5 x ULN
- •EGOG status of < 2: Postoperatively, patients demonstrate an ECOG score of 1 or
- •However, during the first cycle of chemotherapy, the patients' performance status improves to <
- •Projected life expectancy of at least 3 months
- •Ability to comply with the visit schedule and assessments required by the protocol
- •Negative pregnancy test for women of childbearing potential
- •Signed, IRB approved informed consent and HIPPA consent
排除标准
- •Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas) are not eligible.
- •Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
- •An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
- •Subjects with concomitant malignancy or a previous malignancy within the past three (3) years (except non-melanoma skin cancer)
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- •Screening clinical laboratory values of:
- •ANC of <1500/DL Platelet count of <100,000/µL Total bilirubin of *1.5 mg/dL x ULN SGOT (AST) or SGPT (ALT) * 2.5 x ULN Serum creatinine of * 1.5 mg/dL Hemoglobin of * 9 gm/dL (may be transfused or receive a colony stimulating factor to maintain or exceed this level)
- •EGOG status of > 2
- •Gastrointestinal obstruction or an active peptic ulcer
- •Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
- •Known active HIV and viral hepatitis infections
- •Inability to comply with study
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
研究组 & 干预措施
Fosaprepitant
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3
干预措施: fosaprepitant (Drug)
Fosaprepitant
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3
干预措施: Oral Placebo (Other)
Aprepitant
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1
干预措施: aprepitant (Drug)
Aprepitant
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1
干预措施: IV placebo (Other)
结局指标
主要结局
Overall Complete Response Rate
时间窗: 13 months
no emetic episodes or rescue therapy following the initiation of chemotherapy
次要结局
- Impact on Daily Living Activities(13 months)