A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,312
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Paclitaxel (Drug)
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.
干预措施: Carboplatin (Drug)
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.
干预措施: Paclitaxel (Drug)
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.
干预措施: Carboplatin (Drug)
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.
干预措施: Gemcitabine Hydrochloride (Drug)
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.
干预措施: Paclitaxel (Drug)
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.
干预措施: Carboplatin (Drug)
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.
干预措施: Pegylated Liposomal Doxorubicin Hydrochloride (Drug)
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.
干预措施: Paclitaxel (Drug)
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.
干预措施: Carboplatin (Drug)
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.
干预措施: Topotecan Hydrochloride (Drug)
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.
干预措施: Paclitaxel (Drug)
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.
干预措施: Carboplatin (Drug)
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.
干预措施: Gemcitabine Hydrochloride (Drug)
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.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Progression-free Survival
时间窗: From the date of enrollment to first progression or death or last contact, if alive and progression free.
Median duration in months of progression free survival.
Overall Survival
时间窗: Up to 9 years
Proportion of participants whose overall survival exceeded 5 years.
次要结局
- Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0(Up to 9 years)