Whitehead R P, Earhart R H, Fleming T, Goodman P, Macdonald J S, Pollock T, Ungerleider J S
University of New Mexico.
Invest New Drugs. 1990 Aug;8(3):295-7. doi: 10.1007/BF00171840.
In this phase II trial, menogaril was administered to patients with metastatic colon cancer at a dose of 200 mg/m2 IV over one hour with cycles repeated every 28 days provided the absolute granulocyte count was greater than or equal to 2000 cells/microliters. Dose adjustments up or down were made depending upon nadir counts. Twenty-four patients were entered on this study with 21 eligible and evaluable for response. There was 1 CR lasting four and one-half months and 1 PR lasting three months for an overall CR + PR rate of 10% with a 95% confidence interval of 1% to 30%. Six patients (29%) had stable disease and 13 (62%) progressed. Median survival is 13.1 months. Toxicity was primarily hematologic with two cases of life-threatening leukopenia (less than 1000 cells/microliters) and one case of life-threatening granulocytopenia (less than 250 cells/microliters) among the 21 eligible patients, and one case of life-threatening leukopenia and granulocytopenia in one ineligible patient. There were no deaths due to treatment.
在这项II期试验中,以200mg/m²的剂量静脉注射美诺加里尔,给药时间为1小时,每28天重复一个周期,前提是绝对粒细胞计数大于或等于2000个细胞/微升。根据最低点计数进行剂量上调或下调。24名患者进入本研究,其中21名符合条件并可评估疗效。有1例完全缓解持续4个半月,1例部分缓解持续3个月,总完全缓解 + 部分缓解率为10%,95%置信区间为1%至30%。6名患者(29%)疾病稳定,13名(62%)病情进展。中位生存期为13.1个月。毒性主要为血液学毒性,在21名符合条件的患者中有2例危及生命的白细胞减少(低于1000个细胞/微升)和1例危及生命的粒细胞减少(低于250个细胞/微升),1名不符合条件的患者中有1例危及生命的白细胞减少和粒细胞减少。没有因治疗导致的死亡。