A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
研究概览
简要总结
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.
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
- •Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
- •Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
- •Prior radiation therapy is allowed
- •Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.
排除标准
- •More than 2 lines of therapy for ovarian or primary peritoneal cancer.
- •Pregnant or breast feeding.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
研究组 & 干预措施
Pemetrexed/Carboplatin Phase 1
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
干预措施: Pemetrexed - Phase 1 (Drug)
Pemetrexed/Carboplatin Phase 1
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
干预措施: Carboplatin - Phase 1 (Drug)
Pemetrexed/Carboplatin Phase 2
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
干预措施: Pemetrexed - Phase 2 (Drug)
Pemetrexed/Carboplatin Phase 2
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
干预措施: Carboplatin - Phase 2 (Drug)
结局指标
主要结局
Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
时间窗: First treatment to toxicity (up to 18 months)
MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m\^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL\*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.
Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)
时间窗: baseline to measured progressive disease (PD) (up to 18 months)
Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)\*100
次要结局
- Phase 1 - Number of Dose-Limiting Toxicities (DLTs)(baseline through end of Phase 1 (up to 18 months))
- Phase 1 - Number of Participants With Adverse Events (Toxicity)(baseline measured to progressive disease (up to 18 months))
- Phase 1 - Recommended Dose of Pemetrexed for Phase 2(baseline measured to progressive disease (up to 18 months))
- Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2(baseline measured to progressive disease (up to 18 months))
- Phase 1 - Number of Participants With Tumor Response(baseline measured to progressive disease (up to 18 months))
- Phase 2 - Time to Response (TTR)(First treatment to response (up to 31 months))
- Phase 2 - Duration of Response (DOR)(time of response to progressive disease (up to 31 months))
- Phase 2 - Time to Disease Progression(baseline to measured progressive disease (up to 31 months))
- Phase 2 - Time to Treatment Failure(First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months))
- Phase 2 - Overall Survival(baseline to date of death from any cause (up to 31 months))
- Phase 2 - Number of Participants With Adverse Events (Toxicity)(baseline through end of Phase 2 (up to 31 months))
- Phase 2 - Progression-Free Survival(baseline to measured progressive disease (up to 31 months))