NCT00017498已完成2 期
Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck
European Organisation for Research and Treatment of Cancer - EORTC14 个研究点 分布在 3 个国家目标入组 21 人开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 14
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 gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.
详细描述
OBJECTIVES:
- Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck.
- Determine the acute toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks until disease progression and then every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist
- •Symptomatic and/or progressive disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •No bone metastases as only lesion
- •Prior radiotherapy to only target lesion allowed if it has progressed or reappeared after radiotherapy
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN) (2.5 times ULN if liver metastases present)
- •AST or ALT less than 3 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.7 mg/dL
- •No uncontrolled infection
- •No concurrent serious systemic disorders that would preclude study
- •No other prior or concurrent malignancy except:
- •Adequately treated carcinoma in situ of the cervix
- •Basal cell or squamous cell skin cancer
- •Any malignancy that occurred more than 5 years ago with no symptoms or signs of recurrence (except malignant melanoma, hypernephroma, or breast carcinoma)
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent anti-estrogen therapy
- •Concurrent steroid replacement or steroids as an antiemetic allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy except for palliative radiotherapy to bone lesions
- •No concurrent radiotherapy
- •Not specified
- •At least 1 month since prior investigational agents
- •No other concurrent experimental medications
排除标准
- 未提供
研究者
研究点 (14)
Loading locations...
相似试验
已完成
2 期
Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and PaclitaxelBreast CancerNCT00003540Memorial Sloan Kettering Cancer Center30
已完成
2 期
Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous LeukemiaLeukemiaNCT00006462Children's Oncology Group32
已完成
2 期
Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic CancerPancreatic CancerNCT00049348Eastern Cooperative Oncology Group
已完成
2 期
Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the UrotheliumTransitional Cell Cancer of the Renal Pelvis and UreterUrethral CancerBladder CancerNCT00014274European Organisation for Research and Treatment of Cancer - EORTC238
已完成
2 期
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung CancerLung CancerNCT00030433SWOG Cancer Research Network85