Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
研究概览
地位
详细说明
OBJECTIVES:
Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.
Determine the response rate in patients with measurable disease treated with these regimens.
Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.
OUTLINE:
This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I. Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months.
PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19103
- Gynecologic Oncology Group
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
The following are ineligible:
- Germ cell tumors
- Sex cord-stromal tumors
- Carcinosarcomas
- Mixed Mullerian tumors or carcinosarcomas
- Metastatic carcinomas from other sites to theovary
- Low malignant potential tumors, including micropapillary serouscarcinomas
- Mucinous primary peritoneal carcinoma
- Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
Prior breast cancer allowed provided the following are true:
- Disease-free for more than 5 years
- No prior cytotoxic chemotherapy for breast cancer
Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
- Stage no greater than IB
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
- Performance status - GOG 0-2
- 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)
- AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No acute hepatitis
- Creatinine no greater than 1.5 times ULN
- No unstable angina
- No myocardial infarction within the past 6 months
- No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No greater than grade 1 sensory or motor neuropathy
- No active infection that requires antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No severe or ongoing gastrointestinal bleeding that requires blood product support
- See Disease Characteristics
Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
- No prior radiotherapy to any portion of the abdominal cavity or pelvis
Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
- See Disease Characteristics
- No more than 12 weeks since prior surgical resection
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Arm I
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
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鉴于IV
鉴于IV
其他名称:
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实验性的:Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
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鉴于IV
鉴于IV
其他名称:
鉴于IV
其他名称:
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实验性的:Arm III
Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
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鉴于IV
鉴于IV
其他名称:
其他名称:
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实验性的:Arm IV
Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses.
Patients then receive 4 courses of arm I chemotherapy.
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鉴于IV
鉴于IV
其他名称:
鉴于IV
其他名称:
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实验性的:Arm V
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses.
Patients then receive 4 courses of arm I chemotherapy.
Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
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鉴于IV
鉴于IV
其他名称:
鉴于IV
其他名称:
进行手术
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Overall Survival
大体时间:Up to 9 years
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Proportion of participants whose overall survival exceeded 5 years.
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Up to 9 years
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Progression-free Survival
大体时间:From the date of enrollment to first progression or death or last contact, if alive and progression free.
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Median duration in months of progression free survival.
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From the date of enrollment to first progression or death or last contact, if alive and progression free.
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次要结果测量
结果测量 |
大体时间 |
---|---|
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
大体时间:Up to 9 years
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Up to 9 years
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合作者和调查者
调查人员
- 首席研究员:Michael Bookman、Gynecologic Oncology Group
出版物和有用的链接
一般刊物
- Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086. Erratum In: Obstet Gynecol. 2019 Apr;133(4):830.
- Han MK, Tayob N, Murray S, Dransfield MT, Washko G, Scanlon PD, Criner GJ, Casaburi R, Connett J, Lazarus SC, Albert R, Woodruff P, Martinez FJ. Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1503-8. doi: 10.1164/rccm.201402-0207OC.
- Nickles Fader A, Java J, Ueda S, Bristow RE, Armstrong DK, Bookman MA, Gershenson DM; Gynecologic Oncology Group (GOG)*. Survival in women with grade 1 serous ovarian carcinoma. Obstet Gynecol. 2013 Aug;122(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e31829ce7ec.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GOG-0182 (其他标识符:CTEP)
- U10CA027469 (美国 NIH 拨款/合同)
- NCI-2012-02376 (注册表标识符:CTRP (Clinical Trial Reporting Program))
- SWOG-G0182
- CDR0000068467
- ISRCTN41636183
- MRC-ICON5
- ECOG-G0182
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