NCT00023907终止2 期
A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant 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
- 88
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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer
- •Measurable disease
- •At least 1 lesion measured in at least 1 dimension
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •At least 1 target lesion
- •Tumors within a previously irradiated field considered non-target lesions
- •Paclitaxel resistant
- •Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
- •Progression during prior paclitaxel-based therapy
- •Platinum resistant or refractory
- •Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
- •Progression during prior platinum-based therapy
- •Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •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)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No grade 2 or greater neuropathy (sensory and motor)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic or immunologic agents for cancer
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for cancer and recovered
- •Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
- •Initial treatment may include high-dose therapy, consolidation, or extended therapy
- •Received at least 1 prior paclitaxel-based chemotherapy regimen
- •No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
- •No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy for cancer
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy for cancer and recovered
- •No prior radiotherapy to site(s) of measurable disease
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (88)
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