A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of People With Adverse Effects
研究概览
简要总结
Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.
II. Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE:
Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer
- •Recurrent or persistent disease
- •Platinum AND taxane-resistant or refractory disease
- •Progressed during therapy
- •Refractory disease within 6 months of therapy
- •Measurable disease
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
- •Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
- •No active brain metastases
- •Performance status - GOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No sensory or motor neuropathy > grade 1
- •No dementia or altered mental status
- •No other serious uncontrolled medical disorder
- •No active infection requiring antibiotics
- •No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •At least 3 weeks since prior biologic therapy
- •At least 3 weeks since prior immunotherapy
- •Must have received:
- •1 prior combination taxane-based and platinum-based chemotherapy regimen
- •1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen
- •Initial treatment may include high-dose therapy, consolidation, or extended therapy
- •At least 3 weeks since prior chemotherapy and recovered
- •No prior ixabepilone
- •No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen
- •At least 1 week since prior hormonal anticancer therapy
- •Concurrent hormone replacement therapy allowed
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to site(s) of measurable disease
- •No radiotherapy to > 25% of marrow-containing areas
- •Recovered from recent surgery
- •At least 3 weeks since other anticancer therapy
- •No prior anticancer therapy that precludes study participation
- •No concurrent food supplements (e.g., St. John's wort)
- •No concurrent amifostine or other protective agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (ixabepilone)
Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
干预措施: ixabepilone (Drug)
结局指标
主要结局
Number of People With Adverse Effects
时间窗: Every cycle until completion of study treatment up to 30 days after stopping study treatment
Tumor Response
时间窗: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
次要结局
- Progression Free Survival(From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up)
- Overall Survival(From study entry to death or last contact, up to 5 years of follow-up.)