NCT00006812终止2 期
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 61
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
- Determine the nature and degree of toxicity of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer
- •Measurable disease
- •At least 1 unidimensionally measurable lesion
- •Ascites and pleural effusions are not considered measurable disease
- •Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
- •Treatment-free interval of 6-12 months after response to platinum therapy
- •Not eligible for higher priority GOG protocol
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least lower limit of normal
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine clearance at least 50 mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No neuropathy (sensory and motor) greater than grade 1
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No concurrent active infection requiring antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic or immunologic therapy
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy:
- •See Disease Characteristics
- •If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
- •No prior capecitabine or fluorouracil
- •No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
- •Recovered from prior chemotherapy
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy directed at malignant tumor
- •Concurrent continuation of hormone replacement therapy allowed
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to site(s) of measurable disease
- •No prior radiotherapy to more than 25% of bone marrow
- •Recovered from prior surgery
- •No prior cancer treatment that would preclude study therapy
- •No concurrent amifostine or other protective reagents
排除标准
- 未提供
研究者
研究点 (61)
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