PURPOSE: This was a phase I study evaluating the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of weekly docetaxel, doxorubicin and daily oral cyclophosphamide with G-CSF support (ConTAC regimen). PATIENTS AND METHODS: Cohorts of 3-6 patients with advanced breast or other solid malignancies were entered at subsequently higher dose levels until dose-limiting toxicities (DLT) were noted in 2 or more patients per dose level during the first 6 weeks of therapy. This study escalated dosages of docetaxel and doxorubicin simultaneously, while the dose of oral cyclophosphamide was fixed at 60 mg/m(2) daily. RESULTS: Sixteen patients were enrolled. Grade 3-4 adverse events during the first 6 weeks of treatment were neutropenia (n = 1 at dose level #1 and n = 3 at dose level #4), anemia (n = 2 at dose levels 1 and 4), and nausea/vomiting (n = 1 at dose level #4). After 6 weeks of therapy, grade 3-4 toxicities included anemia (n = 3), neutropenia (n = 7), Hand-Foot syndrome (n = 2) and grade 3 cystitis and pneumonia (n = 1 at dose level #4). Five patients with advanced breast cancer and 1 patient with metastatic lung cancer responded to the chemotherapy. CONCLUSIONS: Grade 4 neutropenia was the DLT. The MTD, was established at dose level #3 (doxorubicin at 25 mg/m(2) and docetaxel at 25 mg/m(2) weekly with oral cyclophosphamide dose of 60 mg/m(2) daily). Myelosuppression at that dose level was moderate with G-CSF given concurrently.
PURPOSE: This was a phase I study evaluating the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of weekly docetaxel, doxorubicin and daily oral cyclophosphamide with G-CSF support (ConTAC regimen). PATIENTS AND METHODS: Cohorts of 3-6 patients with advanced breast or other solid malignancies were entered at subsequently higher dose levels until dose-limiting toxicities (DLT) were noted in 2 or more patients per dose level during the first 6 weeks of therapy. This study escalated dosages of docetaxel and doxorubicin simultaneously, while the dose of oral cyclophosphamide was fixed at 60 mg/m(2) daily. RESULTS: Sixteen patients were enrolled. Grade 3-4 adverse events during the first 6 weeks of treatment were neutropenia (n = 1 at dose level #1 and n = 3 at dose level #4), anemia (n = 2 at dose levels 1 and 4), and nausea/vomiting (n = 1 at dose level #4). After 6 weeks of therapy, grade 3-4 toxicities included anemia (n = 3), neutropenia (n = 7), Hand-Foot syndrome (n = 2) and grade 3 cystitis and pneumonia (n = 1 at dose level #4). Five patients with advanced breast cancer and 1 patient with metastatic lung cancer responded to the chemotherapy. CONCLUSIONS: Grade 4 neutropenia was the DLT. The MTD, was established at dose level #3 (doxorubicin at 25 mg/m(2) and docetaxel at 25 mg/m(2) weekly with oral cyclophosphamide dose of 60 mg/m(2) daily). Myelosuppression at that dose level was moderate with G-CSF given concurrently.
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Authors: I Craig Henderson; Donald A Berry; George D Demetri; Constance T Cirrincione; Lori J Goldstein; Silvana Martino; James N Ingle; M Robert Cooper; Daniel F Hayes; Katherine H Tkaczuk; Gini Fleming; James F Holland; David B Duggan; John T Carpenter; Emil Frei; Richard L Schilsky; William C Wood; Hyman B Muss; Larry Norton Journal: J Clin Oncol Date: 2003-03-15 Impact factor: 44.544
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Authors: Mehmet Asim Bilen; Diana H Cauley; Bradley J Atkinson; Hsiang-Chun Chen; Diana H Kaya; Xuemei Wang; Raghu Vikram; Shi-Ming Tu; Paul G Corn; Jeri Kim Journal: Clin Genitourin Cancer Date: 2016-12-13 Impact factor: 2.872