A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
研究概览
简要总结
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free and overall survival of patients treated with this regimen.
- Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- •Recurrent or persistent disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Must have ≥ 1 target lesion to assess response
- •Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
- •Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- •Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
- •Must meet any 1 of the following criteria for platinum-based therapy:
- •Disease progression during therapy
- •Treatment-free interval after completion of treatment < 12 months
- •Disease persistence after completion of therapy
- •Ineligible for a higher priority GOG clinical trial
- •PATIENT CHARACTERISTICS:
- •GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL (transfusions allowed)
- •Creatinine < 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2 times ULN
- •Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
- •AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Able to swallow tablets
- •No sensory or motor neuropathy > grade 1
- •No active infection requiring antibiotics
- •No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
- •No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior surgery, radiotherapy, or chemotherapy
- •At least 1 week since prior anticancer hormonal therapy
- •No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
- •At least 4 weeks since other prior anticancer therapy, including immunotherapy
- •At least 30 days since prior investigational drugs
- •No prior enzastaurin hydrochloride
- •No prior radiotherapy to > 25% of marrow-bearing areas
- •No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
- •No prior treatment that would preclude treatment on this protocol
- •No concurrent chemotherapy, immunotherapy, or other experimental medications
- •No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
- •No other concurrent systemic anticancer therapy
- •No concurrent radiotherapy, including palliative radiotherapy
- •No concurrent agents that stimulate thrombopoiesis
- •No concurrent amifostine or other protective reagents
- •Concurrent hormone replacement therapy allowed
- •Concurrent bisphosphonates allowed provided bony metastases are present
排除标准
- 未提供
结局指标
主要结局
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
时间窗: CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for 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.
Progression-free Survival > 6 Months Using RECIST 1.0
时间窗: CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Number of participants with a maximum grade of 3 or higher during the treatment period.
次要结局
- Duration Overall Survival(Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.)
- Duration of Progression-free Survival (PFS)(CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.)
- Prognostic Factor - Number of Patients With Platinum Sensitivity(Baseline)
- Prognostic Factor - Initial Performance Status(Baseline)
- Prognostic Factor - Age at Study Entry(Baseline)