A Phase II Trial of Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients With a BSA > 2.0
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
研究概览
简要总结
The purpose of this study is to evaluate the side effects and effectiveness of giving standard paclitaxel chemotherapy in doses based on actual body surface area in combination with standard dosed carboplatin chemotherapy for overweight women.
详细描述
Primary Objective The primary objective is to prospectively evaluate the Relative Dose Intensity (RDI) and toxicity of weight-based dose dense weekly paclitaxel and carboplatin in overweight patients with a BSA > 2.0 compared to the Japanese Gynecologic Oncology Group trial (JGOG 2016) during 6 - 9 cycles of chemotherapy.
Secondary Objective(s) The secondary objective is to evaluate progression-free survival in this patient population.
Study Design This is a descriptive study to determine what the relative dose intensity of patients who are overweight with a BSA of greater than 2.0 can achieve.
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
- •Patients with a histologically confirmed or presumed diagnosis of gynecologic malignancy for whom chemotherapy with paclitaxel and carboplatin is planned.
- •Body Surface area >2.0
- •Patients must have adequate:
- •Renal function: Creatinine <1.5 x Institutional upper limits of normal (ULN)
- •Bone marrow function:
- •Absolute neutrophil count (ANC) ≥ 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
- •Platelets ≥ 100,000/mcl.
- •Hepatic function:
- •Bilirubin ≤ 1.5 x ULN.
- •Aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x ULN.
- •Alkaline phosphatase ≤ to 2.5 x ULN.
- •Neurologic function:
- •Neuropathy (sensory and motor) ≤ CTCAE Grade
- •Patients must have a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or
- •Patients must be entered within 12 weeks of diagnosis.
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- •Patients who have received prior chemotherapy.
- •Patients with acute hepatitis or active infection that requires parenteral antibiotics.
- •Patients with clinically significant cardiovascular disease. This includes:
- •Myocardial infarction or unstable angina < 6 months prior to registration.
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate.
- •Patients who are pregnant or nursing.
- •Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.
- •Patients with known allergy to cremophor or polysorbate 80.
研究组 & 干预措施
Paclitaxel + Carboplatin
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
干预措施: Paclitaxel (Drug)
Paclitaxel + Carboplatin
Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
时间窗: Up to 190 days
Prospective evaluation of the Relative Dose Intensity (RDI) of weight-based dose dense weekly paclitaxel and carboplatin as measured by the average percent of completed treatment cycles out of the intended therapeutic plan
次要结局
- Number of Participants With Progression-free Survival (PFS)(every 3 months for up to 2 years, then every 6 months (up to 31 months))