A Phase II Study of Atrasentan (ABT-627) Plus DOXIL in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Median Time to Tumor Progression
研究概览
简要总结
RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy.
PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- To determine the median time to tumor progression in patients with recurrent ovarian epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary adenocarcinoma treated with Doxil and atrasentan hydrochloride.
Secondary
- To determine the objective response rate and survival of patients treated with this regimen.
- To determine the toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed adenocarcinoma arising from the ovary, fallopian tubes, or peritoneum (i.e., peritoneal serous papillary adenocarcinoma)
- •Received prior treatment with either cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
- •Radiographic evidence of progressive disease and/or a doubling of CA-125 levels ≥ 70 IU/mL following first-line chemotherapy
- •Measurable disease as defined by RECIST criteria
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/μL
- •Hemoglobin ≥ 9.5 g/dL
- •Platelets > 100,000/μL
- •Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times ULN
- •AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)
- •LVEF ≥ 50% by MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Surgically sterile or must use effective contraception
- •No known HIV positivity or AIDS
- •No uncontrolled heart disease, diabetes, or other medical condition that would place the patient at unacceptably high risk for toxicity
- •No New York Heart Association class I-IV heart failure
排除标准
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior toxicities to ≤ grade 1 by NCI-CTC Version 2 criteria
- •No other prior systemic therapies for this cancer except cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
- •More than 4 weeks since prior chemotherapy
- •No concurrent anticancer therapy
研究组 & 干预措施
Therapeutic Intervention
干预措施: atrasentan hydrochloride (Drug)
Therapeutic Intervention
干预措施: doxil (Drug)
结局指标
主要结局
Median Time to Tumor Progression
时间窗: Date on study to the date of measured progressive disease, every 2 cycles (2 months)
Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level \>=2x baseline and \>=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
次要结局
- Number of Patients With Objective Response(At month 2 and monthly thereafter to cessation of treatment)
- Overall Survival(Date on study to date of death from any cause)
- Number of Patients With Worst Grade Toxicities(Weekly for 2 weeks, then monthly for 5 months)
研究者
Marta Crispens, MD
Associate Professor; Gynecological Oncologist
Vanderbilt-Ingram Cancer Center