A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- Duration of Overall Survival (OS)
研究概览
简要总结
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
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
- 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 squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- •Stage IVB, recurrent, or persistent disease
- •Not amenable to curative surgery and/or radiotherapy
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- •Biopsy confirmation required if lesion is less than 30 mm
- •Target lesion must be outside of a previously irradiated field
- •No craniospinal metastases
- •Performance status - GOG 0-1
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •Alkaline phosphatase no greater than 3 times normal
- •AST no greater than 3 times normal
- •Creatinine ≤ 1.2 mg/dL
- •Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
- •No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior malignancy whose treatment contraindicates the current study therapy
- •No concurrent clinically significant infection
- •No concurrent cytokines
- •At least 6 weeks since prior chemoradiotherapy and recovered
- •No prior chemotherapy (except when concurrently administered with radiotherapy)
- •At least 3 weeks since prior radiotherapy and recovered
- •Recovered from prior surgery
排除标准
- 未提供
研究组 & 干预措施
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
干预措施: Cisplatin (Drug)
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
干预措施: Paclitaxel (Drug)
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
干预措施: Quality-of-Life Assessment (Other)
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
干预措施: Cisplatin (Drug)
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
干预措施: Vinorelbine Tartrate (Drug)
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
干预措施: Cisplatin (Drug)
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
干预措施: Gemcitabine Hydrochloride (Drug)
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
干预措施: Quality-of-Life Assessment (Other)
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
干预措施: Cisplatin (Drug)
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
干预措施: Quality-of-Life Assessment (Other)
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
干预措施: Topotecan Hydrochloride (Drug)
结局指标
主要结局
Duration of Overall Survival (OS)
时间窗: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
次要结局
- Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)
- Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)
- Frequency of Response Using RECIST Version 1.0(Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years))
- Duration of Progression-free Survival (PFS)(Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years))
- Pain, Assessed by Brief Pain Inventory(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)