A Phase I Study Using Low-Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART) As A Docetaxel Chemo-Potentiator for Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and determine the recommended phase II dose of combining the effect of LDFWART following administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible
- •1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.
- •Patients must have a life expectancy of at least 6 months.
- •Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website).
- •Age 18 - 80 years old
- •Patients must have an adequate bone marrow, renal, and hepatic function:
- •5.1 WBC: ≥ 3,000 /mcl
- •5.2 ANC: ≥ 1,500 /mcl
- •5.3 Platelets: ≥ 100,000 /mcl
- •5.4 Creatinine: < 2.0 mg/dcl
- •5.5 Bilirubin: < 1.5x institutional normal value
- •5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:< 3x institutional normal value.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.
- •Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry.
- •Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).
- •Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment.
- •Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
- •Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor).
- •Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.
- •Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.
- •Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care.
- •Patients that are < 18 yrs. of age or > 80 yrs. of age.
研究组 & 干预措施
LDFWART + Docetaxel
This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning Docetaxel and afternoon Low Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART). The first day of the first treatment is designated "study day 1".
干预措施: Low Dose Fractionated Whole Abdominal Radiation Therapy (Radiation)
LDFWART + Docetaxel
This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning Docetaxel and afternoon Low Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART). The first day of the first treatment is designated "study day 1".
干预措施: Docetaxel (Drug)
结局指标
主要结局
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
时间窗: 3 years
Number of subjects experiencing adverse events after receiving protocol therapy.
Recommended Phase II Dose of LDFWART
时间窗: 3 years
The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.
次要结局
- The rate of Overall Survival in subjects receiving protocol therapy(Up to 5 years)
- Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy(Up to 5 years)
- The rate of Progression-Free Survival in subjects receiving protocol therapy.(Up to 5 years)
研究者
Aaron Wolfson
Professor
University of Miami