title: Phase I study with a weekly 1 h infusion of paclitaxel in heavily pretreated patients with metastatic breast and ovarian cancer.
abstract: Paclitaxel has proven to be an active agent in the treatment of breast and ovarian cancer [Seidman AD, Ann Oncol 1994, 5 (Suppl. 6), 17-22], but the optimal dose and schedule remain undefined. We performed a phase I study with a weekly 1 h infusion of paclitaxel. After premedication, patients received a 1 h infusion of paclitaxel on days 1, 8, 15, 22, 29 and 36 (every 50 days) using the following dose levels: dose level 1 70 mg/m2, dose level 2 80 mg/m2, dose level 90 mg/m2, dose level 4 100 mg/m2, 20 patients (17 breast, 3 ovarian cancer) with anthracycline- or platinum-refractory disease entered this trial. No dose limiting toxicities occurred at dose levels 1-3. 2 of the 4 patients at dose level 4 had neutropenia WHO grade 4. At all dose levels responses could be observed. Maximal tolerable dose (MTD) was reached using dose level 4. Paclitaxel, given in a weekly 1 h infusion, is safe and shows mild toxicity in heavily pretreated breast and ovarian cancer patients. We recommend dose level 3 for phase II studies.
authors.affiliation: Department of Internal Medicine (Cancer Research), University of Essen, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Klaassen
authors.forename: H
authors.initials: H
authors.lastname: Wilke
authors.forename: D
authors.initials: D
authors.lastname: Strumberg
authors.forename: W
authors.initials: W
authors.lastname: Eberhardt
authors.forename: M
authors.initials: M
authors.lastname: Korn
authors.forename: S
authors.initials: S
authors.lastname: Seeber
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel