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- Title
Phase I trial of concurrent administration of topotecan and docetaxel for cancer treatment.
- Authors
Ishmael DR; Liu H; Nordquist JA; Nordquist RE; Chen WR
- Abstract
Docetaxel and topotecan have been used as individual chemotherapy agents in cancer treatment. However, the combined effect of these two drugs has not been thoroughly investigated. In a phase I clinical trial, patients previously treated with chemotherapy were treated with concurrent administration of the two drugs; topotecan was administered as a 30-minute infusion, followed by a 30- minute docetaxel infusion. The treatment cycle was a bi-weekly regimen with three infusions of topotecan and docetaxel (6 weeks in all) followed by a one-week rest. The original protocol started with 3 mg/m2 of topotecan and 60 mg/m2 of docetaxel; 3 of the 6 patients treated at this level experienced grade 4 neutropenia dose-limiting-toxicity (DLT). The dose level was subsequently revised to start with 3 mg/m2 of topotecan and 40 mg/m2 of docetaxel and then escalated to 4 mg/m2 of topotecan and 50 mg/m2 of docetaxel. Twenty-one patients were treated with the revised dose levels; only two patients experienced grade 4 neutropenia during the treatment and maximum tolerated dose was not reached. Other hematologic toxicities, such as thrombocytopenia and anemia, were noticeably absent in the patients treated with the revised protocol. Non-hematologic toxicity was rare and only at low levels for all the patients. Among the 8 breast cancer patients, 1 complete response (CR), 2 partial responses (PR), 1 minor response (MR) and 2 stable disease (SD) were observed; among the 6 small cell lung cancer patients (SCLC), 1 CR, 1 PR and 1 SD were observed. Among the 8 assessable 6 non-small cell lung cancer (NSCLC) patients, one gave a complete response and one gave a minor response.The results of this phase I study showed that the revised dose levels were well tolerated by the patients and the patient responses indicated the effectiveness of the topotecan- docetaxel combination.
- Publication
Journal of Applied Research, 2005, Vol 5, Issue 1, p53
- ISSN
1537-064X
- Publication type
Journal Article