A Phase I Trial of Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients

University of Nebraska1 个研究点分布在 1 个国家目标入组 46 人开始时间: 2004年10月1日最近更新: 2024年1月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Nebraska
入组人数: 46
试验地点: 1
主要终点: Recommended phase II dose of capecitabine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.

详细描述

OBJECTIVES:

Primary

Determine the recommended phase II dose of capecitabine when given together with epirubicin hydrochloride and carboplatin in patients with progressive, unresectable, or metastatic cancer.
Determine the toxicities of this regimen in these patients.

Secondary

Correlate end-of-infusion levels of epirubicin hydrochloride and its metabolites with epirubicin hydrochloride dose and clinical toxicity in these patients.
Correlate the pharmacokinetics of capecitabine with clinical toxicity in these patients.
Determine the possible correlation between polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity in these patients.
Document antitumor activity of this regimen in these patients.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Pathologically confirmed cancer, meeting 1 of the following criteria:
•Disease that has progressed on standard therapy
•Locally advanced but unresectable primary or recurrent solid tumor
•Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists)
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Absolute neutrophil count ≥ 2,000/mm³
•Platelet count ≥ 100,000/mm³
•Bilirubin ≤ 1.5 times upper limit of normal (ULN)
•alanine aminotransferase (ALT) & aspartate aminotransferase (AST) ≤ 2.5 times ULN
•Creatinine ≤ 1.6 mg/dL
•Left ventricular ejection fraction ≥ 50%
•Fertile patients must use effective contraception
•Recovered from prior therapy
•More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy
•At least 2 weeks since prior radiotherapy
•At least 8 weeks since prior strontium therapy
•At least 4 weeks since prior and no concurrent sorivudine or brivudine

排除标准

•No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy)
•No leukemia or lymphoma
•No primary central nervous system (CNS) malignancies or CNS metastases
•No other medical illness that would preclude study treatment
•No active infection requiring IV antibiotic therapy unless the infection has resolved
•No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
•No history of unexpectedly severe intolerance to fluorouracil
•Not pregnant or nursing/negative pregnancy test
•No prior doxorubicin at cumulative doses > 300 mg/m²
•No concurrent combination antiretroviral therapy for HIV-positive patients
•No concurrent cimetidine