A Phase II Evaluation of Bortezomib (Velcade™, PS-341, NSC #681239, IND #58443) in the Treatment of Persistent or Recurrent Platinum-Sensitive Epithelial Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Tumor Response Duration
研究概览
简要总结
Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
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 persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
- •Measurable disease
- •At least 20 mm by conventional techniques (e.g., palpation, x-ray, plain CT scan, or MRI) OR at least 10 mm by spiral CT scan
- •Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen for primary disease (e.g., carboplatin, cisplatin, or other organoplatinum compound)
- •A second regimen containing paclitaxel allowed provided patient received no prior paclitaxel therapy
- •Platinum-sensitive disease
- •Treatment-free interval without progressive disease for more than 6 months but less than 12 months after therapy with platinum-based regimen
- •At least 1 target lesion outside previously irradiated field
- •Ineligible for higher priority GOG protocol
- •Performance status - GOG 0-2 (if received 1 prior therapy regimen)
- •Performance status - GOG 0-1 (if received 2 prior therapy regimens)
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No evidence of acute ischemia or significant conduction abnormality (e.g., left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular block) on electrocardiogram
- •No myocardial infarction within the past 6 months
- •No cerebrovascular event or transient ischemic attack within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No other invasive malignancy within the past 5 years except non-melanoma skin cancer
- •No sensory or motor neuropathy greater than grade 1
- •No more than 1 prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent disease
- •At least 4 weeks since prior biological or immunological agents and recovered
- •No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimen
- •At least 4 weeks since prior chemotherapy and recovered
- •At least 1 week since prior anti-cancer hormonal therapy and recovered
- •Concurrent hormone replacement therapy allowed
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to target lesions
- •No prior radiotherapy to more than 25% of marrow-bearing areas
- •At least 4 weeks since prior surgery and recovered
- •No prior bortezomib
- •No prior anti-cancer therapy that would preclude study treatment
- •No concurrent amifostine or other protective agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (bortezomib)
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
Treatment (bortezomib)
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (bortezomib)
Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
Tumor Response Duration
时间窗: From study entry, up to 5 years
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
时间窗: From study entry until disease progression/intolerable toxicity/study withdrawal
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.
Frequency and Severity of Observed Adverse Events
时间窗: Up to 5 years
次要结局
- Overall Survival(From study entry, up to 5 years following disease progression)
- Progression-Free Survival(From study entry up to 5 years)