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Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors

A Phase I Absolute Bioavailability Study of Oral NAVELBINE (Vinorelbine Tartrate) in Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors.

研究概览

详细说明

OBJECTIVES: I. Compare the pharmacokinetic profiles of vinorelbine administered intravenously on day 1 and orally on day 8 vs the reverse order in patients with metastatic or advanced solid tumors. II. Determine the intersubject variability in the pharmacokinetics of oral vinorelbine. III. Compare the safety profiles of oral vs intravenous vinorelbine in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8. Arm II: Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8. Treatment continues in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed for 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

研究类型

介入性

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Tampa、Florida、美国、33612
        • H. Lee Moffitt Cancer Center and Research Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or advanced solid tumor that will potentially benefit from single agent vinorelbine No known CNS metastases unless successfully treated with excision or radiotherapy and stable for at least 6 months prior to study

PATIENT CHARACTERISTICS: Age: 18-75 Performance status: Not specified Life expectancy: Greater than 3 months Hematopoietic: Hemoglobin at least 9 g/dL (at least 3 weeks since last transfusion) Platelet count at least 75,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminases no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN No unstable or uncontrolled hypercalcemia Cardiovascular: No venous access problems that would preclude blood sampling No symptomatic class II-IV congestive heart failure No significant ventricular arrhythmia requiring drug control No myocardial infarction within the past 6 months No uncontrolled cardiac disease or unstable angina No recurrent thromboembolic events No unstable or uncontrolled arterial hypertension Pulmonary: No history of recurrent aspiration pneumonitis or aspiration pneumonia No severe respiratory insufficiency, defined by oxygen partial pressure less than 60 mm Hg on room air and requirement for chronic oxygen therapy Gastrointestinal: See Surgery No active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption No lack of integrity of the gastrointestinal tract No unstable or uncontrolled diarrhea or peptic ulcer disease Other: Able to receive IV and oral regimens Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 2 weeks before, during, and for at least 9 days after study No preexisting peripheral neuropathy greater than grade 1 No active infection within the past 2 weeks No fever (temperature at least 37.5 degrees C) or other symptoms of possible infection within 10 days after completing antimicrobial treatment No psychological, familial, or sociological condition that would preclude study No unstable or uncontrolled preexisting medical condition (e.g., diabetes, alcohol withdrawal)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior packed red blood cell transfusion At least 1 week since prior platelet transfusion or hematopoietic growth factors No concurrent growth factors earlier than 24 hours after study drug Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No other concurrent antineoplastic agents Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Concurrent megestrol allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Prior or concurrent palliative radiotherapy to peripheral bone lesion, spinal cord compression, or imminent fracture allowed only if less than 10% of bone marrow involved Surgery: No prior significant surgical resection of the stomach or small bowel At least 2 weeks since prior surgery Other: No other concurrent experimental or anticancer drugs or devices At least 1 week since prior products or drugs known to induce or inhibit the enzymatic activity of vinorelbine (e.g., antihistamines, phenobarbital, meprobamate, some antiepileptics, or grapefruit juice) No concurrent products or drugs known to induce or inhibit the enzymatic activity of vinorelbine No concurrent opiates or laxatives

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Daniel M. Sullivan, MD、H. Lee Moffitt Cancer Center and Research Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2000年6月1日

研究注册日期

首次提交

2000年8月3日

首先提交符合 QC 标准的

2004年6月21日

首次发布 (估计)

2004年6月22日

研究记录更新

最后更新发布 (估计)

2013年9月20日

上次提交的符合 QC 标准的更新

2013年9月19日

最后验证

2000年11月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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