A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) 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
- 1
- 主要终点
- Progression-free Survival (PFS) > 6 Months
研究概览
简要总结
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.
详细描述
OBJECTIVES: Primary I. Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib.
II. Determine the nature and degree of toxicity of this drug in these patients.
Secondary I. Determine the clinical response rate (partial and complete response) in patients treated with this drug.
II. Determine the duration of progression-free and overall survival of patients treated with this drug.
III. Determine the impact of prognostic variables, including platinum sensitivity, performance status, and cellular histology (clear cell or mucinous type), on patients treated with this drug.
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 —（Adult, Older Adult）
- 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 cancer
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Presence of ≥ 1 target lesion
- •Tumors within a previously irradiated field are not considered target lesions unless evidence of progression is documented or proven by biopsy 3 months after completion of radiotherapy
- •Disease progression during OR persistent disease after 1 prior platinum-based chemotherapy regimen* for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
- •Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
- •Treatment-free interval after platinum-based chemotherapy < 12 months
- •Tumor accessible by guided core needle or fine needle biopsy
- •Ineligible for any higher priority Gynecologic Oncology Group (GOG) protocols (i.e., any active phase III protocol for the same patient population)
- •Performance status - GOG 0-2 (patients who have received 1 prior treatment regimen)
- •Performance status - GOG 0-1 (patients who have received 2 prior treatment regimens)
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Ejection fraction normal by echocardiogram or MUGA
- •No GI disease resulting in an inability to take oral medication
- •No malabsorption syndrome
- •No requirement for IV alimentation
- •No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- •No active infection requiring antibiotics
- •No sensory or motor neuropathy > grade 1
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib
- •At least 4 weeks since prior immunologic agents for the malignancy
- •No prior trastuzumab (Herceptin®)or cetuximab
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •At least 6 weeks since prior nitrosoureas or mitomycin for the malignancy
- •No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- •At least 2 weeks since prior and no concurrent dexamethasone or dexamethasone equivalent dose > 1.5 mg/day
- •At least 1 week since prior hormonal therapy for the malignancy
- •Concurrent hormone replacement therapy allowed
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •No prior radiotherapy to > 25% of marrow-bearing areas
- •See Disease Characteristics
- •Recovered from prior surgery
- •No prior surgical procedure affecting gastrointestinal (GI) absorption
- •At least 4 weeks since other prior therapy for the malignancy
- •At least 6 months since prior and no concurrent amiodarone
- •At least 1 week since other prior and no concurrent CYP3A4 inhibitors
- •At least 2 weeks since prior and no concurrent CYP3A4 inducers
- •At least 1 week since prior and no concurrent H2 inhibitors or proton pump inhibitors
- 另有 6 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: lapatinib ditosylate (Drug)
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression-free Survival (PFS) > 6 Months
时间窗: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months
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.
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
次要结局
- Tumor Response(Baseline, every other cycle for 6 months and then every 6 months for up to 5 years)
- Overall Survival(From entry into the study to death or the date of last contact, assessed up to 5 years)
- Prognostic Variable: Platinum Sensitivity(Baseline)
- Duration of Progression-free Survival(Every other cycle for 6 months and then every 6 months for up to 5 years.)
- Prognostic Variable: Cellular Histology(Baseline)
- Prognostic Variables: Performance Status(Baseline)