PHASE I DOSE ESCALATION OF MULTIAGENT CHEMOTHERAPY, LEUCOVORIN/GEMZAR

一项研究，以评估联合使用三种药物，甲酰四氢叶酸，5FU和健择，用于癌症患者化疗的益处和副作用。进入本研究的患者患有癌症，尽管接受了标准治疗，但病情仍在进展，或者没有标准治疗。研究登记所需的所有血液检查和体格检查将在开始前7天内完成。X光和扫描必须在初次治疗前不超过五周进行。注册将在治疗开始前一周进行。根据登记时的分配，患者将接受甲酰四氢叶酸，然后是5FU，然后是健择，或者他们将被随机分配接受健择，然后是甲酰四氢叶酸，然后是5FU。所有药物每周给药三次，持续四周。 疾病评估将在第二个治疗周期后进行，除非症状提示早期评估。完全或部分缓解或疾病稳定的患者可考虑接受进一步治疗。继续治疗的患者将在每两个周期或大约每两个月后进行疾病评估。

A study to evaluate the benefits and side effects of the combination of three drugs, leucovorin, 5FU, and Gemzar, used in chemotherapy for cancer patients. Patients who enter this study have cancer, which has progressed despite standard therapy, or for which there is no standard therapy. All blood work and physical examinations necessary for registration in the study will have been done no longer than seven days before starting. X-rays and scans must be done no more than five weeks before the initial treatment. Registration will take place one week before the start of the treatment. Based on assignment at the time of registration, patients will receive either leucovorin followed by 5FU, which is followed by Gemzar, or they will be randomly assigned to receive Gemzar, then leucovorin, then 5FU. All drugs will be given three times a week for four weeks. Disease assessment will follow the second cycle of therapy unless symptoms prompt earlier assessment. Patients with a complete or partial response or stable disease may be considered for further therapy. Patients continuing therapy will have disease assessment after every two cycles, or about every two months.