NCT00030472终止2 期
A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 17
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 liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.
详细描述
OBJECTIVES:
- Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days 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 squamous cell carcinoma (SCC) of the cervix
- •Persistent or recurrent progressive disease
- •Must have failed local therapeutic measures and considered incurable
- •1 prior chemotherapeutic regimen for SCC of the cervix required
- •Initial treatment may include high-dose therapy, consolidation, or extended therapy
- •Ineligible for a higher priority GOG protocol
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •Target lesion may not be within a previously irradiated field
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 100,000/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •Bilirubin no greater than 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 congestive heart failure
- •No unstable angina
- •No myocardial infarction or new cardiac arrhythmia in the past 6 months
- •No active infection requiring antibiotics
- •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:
- •1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management)
- •At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix
- •Chemotherapy:
- •See Disease Characteristics
- •No prior doxorubicin or doxorubicin HCl liposome
- •1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management)
- •No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
- •Recovered from prior chemotherapy
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy for SCC of the cervix
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •At least 3 weeks since other prior therapy for SCC of the cervix
- •No prior anticancer treatment that precludes study
排除标准
- 未提供
研究者
研究点 (17)
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