NCT00093678撤回不适用
A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may also decrease weight loss and improve muscle strength in cancer patients.
PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in managing pain, weight loss, and weakness in patients with advanced cancer.
详细描述
OBJECTIVES:
Primary
- Compare the symptom burden and functional status, as measured by the physical well-being subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), of patients with advanced cancer treated with celecoxib vs placebo.
Secondary
- Compare pain, as measured by the Brief Pain Inventory, in patients treated with these drugs.
- Compare the need for opioid analgesics, as measured by the oral morphine equivalent of analgesics used, in patients treated with these drugs.
- Compare weight loss in patients treated with these drugs.
- Compare quality of life, as measured by the FACT-G, in patients treated with these drugs.
- Compare the median survival of patients treated with these drugs.
- Determine the toxicity of celecoxib in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignant tumor of 1 of the following types:
- •Carcinoma
- •Metastatic or unresectable disease
- •Clear evidence of residual disease after most recent prior treatment
- •Measurable disease not required
- •Patient has elected to receive supportive care only rather than active cancer treatment (e.g., palliative chemotherapy)
- •Brain metastases allowed provided the following criteria are met:
- •Completed treatment for CNS disease (e.g., whole brain radiotherapy, surgery, or stereotactic surgery)
- •Clinically stable disease for at least 4 weeks after treatment completion
- •No requirement for corticosteroids
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •ALT and AST ≤ 5 times ULN
- •Creatinine ≤ 1.6 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No transient ischemic attack within the past 6 months
- •No stroke within the past 6 months
- •No angina pectoris requiring medical therapy
- •No other active coronary artery disease or cerebrovascular disease
- •No active gastrointestinal (GI) ulcer disease
- •No GI bleeding
- •No history of allergic reaction, urticaria, or bronchospasm after taking NSAIDs, aspirin, or sulfonamide drugs
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Concurrent hematopoietic growth factors for cytopenia or fatigue allowed
- •No concurrent biologic anticancer agents
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •See Disease Characteristics
- •No concurrent corticosteroids for management of cancer-related symptoms or other illness
- •No concurrent hormonal therapy
- •Concurrent luteinizing hormone-releasing hormone therapy allowed for prostate cancer patients provided drug was initiated at least 6 months ago AND there is unequivocal evidence of progressive disease, defined by 1 of the following criteria:
- •Rising prostate-specific antigen (PSA) on 3 successive measurements
- •Rising PSA on 2 measurements taken at least 2 weeks apart
- •New lesions on bone scan
- •Radiotherapy
- •See Disease Characteristics
- •See Disease Characteristics
- 另有 3 项未显示
排除标准
- 未提供
研究者
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