Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
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. It is not yet known which combination chemotherapy regimen is more effective for cancer of unknown primary origin.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin.
研究概览
详细说明
OBJECTIVES:
- Compare the overall survival after treatment with paclitaxel, carboplatin, and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary.
- Compare the response rates, progression free survival, toxicity profile, and quality of life between the two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence or absence of liver metastases.
Patients are randomly assigned to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to four courses.
- Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two courses.
Patients are followed every 3 months after treatment for 1 year or until death. Quality of life questionnaires are completed at each follow-up.
PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3 years.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Maastricht、荷兰、6202 AZ
- Academisch Ziekenhuis Maastricht
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Tilburg、荷兰、5022 GC
- St. Elisabeth Ziekenhuis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of any differentiation grade
Excludes the following "treatable" conditions:
- Axillary node involvement
- Peritonitis carcinomatosis
- Blastic bone metastases and/or elevated PSA
- Squamous cell cancer with cervical or inguinal presentation
Poorly differentiated carcinoma
- Neuroendocrine tumors OR
- Tumors located in the mediastinum, retroperitoneum, or nodes
- At least one measurable metastatic site
- No brain or meningeal metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Hematopoietic:
- Leukocyte count at least 4,000/mm3
- Thrombocyte count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.4 mg/dL
- AST and ALT less than 3 times upper limit of normal
- No cirrhosis of the liver
Renal:
- Creatinine less than 1.7 mg/dL
Cardiovascular:
- At least 3 months since myocardial infarction
- No congestive heart failure, tachydysrhythmia, or unstable angina pectoris
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
- No other serious illness or medical condition
- No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow)
Surgery:
- Not specified
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
合作者和调查者
调查人员
- 学习椅:R. L. Jansen, MD, PhD、Academisch Ziekenhuis Maastricht
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DUT-KWF-CKVO-9801
- CDR0000066622 (注册表标识符:PDQ (Physician Data Query))
- EU-98023
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