NCT00020696已完成2 期
A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin 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
- 已完成
- 试验地点
- 107
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of tirapazamine and cisplatin in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive tirapazamine IV over 2 hours followed 1 hour later by cisplatin IV over 30 minutes on day 1. Courses repeat every 3 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.
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 confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Platinum-sensitive disease
- •Treatment-free interval of more than 6 months without clinical evidence of progressive disease after a response to a platinum compound
- •One prior chemotherapy regimen containing cisplatin or another platinum compound for primary disease required
- •Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- •Patients not previously treated with paclitaxel may receive a second regimen containing paclitaxel
- •No additional cytotoxic chemotherapy (including retreatment with initial regimens) for recurrent or persistent disease
- •Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
- •Treatment-free interval of more than 12 months if non-platinum-based GOG-0146 series protocol is active concurrently with this protocol
- •PATIENT CHARACTERISTICS:
- •Not specified
- •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
- •Cardiovascular:
- •No prior or concurrent myocardial infarction or ischemic heart disease
- •No active infection requiring antibiotics
- •No sensory or motor neuropathy greater than grade 1
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic or immunological agents directed at malignant tumor
- •Chemotherapy:
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No prior tirapazamine
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy directed at malignant tumor
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •No prior radiotherapy to site(s) of measurable disease used on this study
- •No prior radiotherapy to more than 25% of bone marrow
- •See Disease Characteristics
- •Recovered from prior surgery
- •No prior cancer treatment that would preclude study
- •At least 3 weeks since other prior therapy directed at malignant tumor
排除标准
- 未提供
研究者
研究点 (107)
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