NCT00023699已完成2 期
A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 105
研究概览
简要总结
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
- Determine the nature and degree of toxicity in patients treated with this drug.
- Determine the partial and complete response rates in patients treated with this drug.
- Determine the duration of progression-free and overall survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily. Courses repeat 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 ovarian epithelial or primary peritoneal carcinoma
- •Recurrent or persistent disease
- •Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
- •Platinum-resistant or refractory
- •Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR
- •Progression during platinum-containing regimen OR
- •Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen
- •At least 1 lesion measurable in at least 1 dimension
- •At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
- •At least 10 mm by spiral CT scan
- •At least 1 target lesion outside a previously irradiated field
- •Disease must be accessible to core needle biopsy
- •Ineligible for higher priority GOG 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 unstable cardiac disease
- •No myocardial infarction within the past 6 months
- •Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No sensory or motor neuropathy greater than grade 1
- •No active corneal disease (e.g., keratoconjunctivitis)
- •No active infection requiring antibiotics
- •No evidence of bowel dysfunction that could be related to early bowel obstruction
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior immunological agents for the malignancy
- •No concurrent anti-cancer immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease
- •No prior noncytotoxic chemotherapy for recurrent or persistent disease
- •At least 3 weeks since prior chemotherapy for the malignancy and recovered
- •No concurrent anti-cancer chemotherapy
- •Endocrine therapy:
- •At least 1 week since prior anticancer hormonal therapy
- 另有 16 项未显示
排除标准
- 未提供
研究者
研究点 (105)
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