Investigational New Drugs

, Volume 28, Issue 4, pp 502–508

Phase I trial of weekly docetaxel, weekly doxorubicin, daily oral cyclophosphamide, and G-CSF (ConTAC Regimen)in advanced malignancies

  • Robert Wesolowski
  • David Peereboom
  • Patricia Weiss
  • Paul Elson
  • George Thomas Budd
PHASE I STUDIES

DOI: 10.1007/s10637-009-9258-0

Cite this article as:
Wesolowski, R., Peereboom, D., Weiss, P. et al. Invest New Drugs (2010) 28: 502. doi:10.1007/s10637-009-9258-0
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Summary

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/m2 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/m2 and docetaxel at 25 mg/m2 weekly with oral cyclophosphamide dose of 60 mg/m2 daily). Myelosuppression at that dose level was moderate with G-CSF given concurrently.

Keywords

Docetaxel Doxorubicin Oral cyclophosphamide ConTAC regimen Phase I trial Advanced breast cancer Solid tumors 

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  • Robert Wesolowski
    • 1
  • David Peereboom
    • 1
  • Patricia Weiss
    • 1
  • Paul Elson
    • 1
  • George Thomas Budd
    • 1
  1. 1.Cleveland ClinicTaussig Cancer InstituteClevelandUSA

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