International Journal of Clinical Oncology

, Volume 20, Issue 3, pp 474–479 | Cite as

A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer

  • Goro Kutomi
  • Tousei Ohmura
  • Fukino Satomi
  • Hideki Maeda
  • Hiroaki Shima
  • Hidekazu Kameshima
  • Minoru Okazaki
  • Hideji Masuoka
  • Kenichi Sasaki
  • Koichi Hirata
Original Article
  • 271 Downloads

Abstract

Background

The objective of the present clinical study is to determine the maximum tolerated dose (MTD)/recommended dose (RD) of combination therapy with nanoparticle albumin-bound paclitaxel (nab-PTX) and cyclophosphamide (CPA) in patients with metastatic or recurrent breast cancer.

Methods

nab-PTX and CPA were administered on the first day of each 21-day treatment cycle. The dose of CPA was fixed at 600 mg/m2, while the dose of nab-PTX was increased from 180 mg/m2 (Level 1) to 220 mg/m2 (Level 2) and then to 260 mg/m2 (Level 3).

Results

A total of 11 patients from two institutions were enrolled in the present study. At Level 3, a dose-limiting toxicity (DLT) was observed in 1 patient. Considering treatment continuity and the risk of adverse events in Cycle 2 and thereafter at this level, further subject enrollment at Level 3 was discontinued after two patients had been enrolled.

Since the doses used at Level 3 were considered the MTD of nab-PTX and CPA and the doses used at Level 2 were considered the RD of nab-PTX and CPA, three additional subjects were enrolled at Level 2. No DLTs were observed at Level 2.

Conclusion

The RD of combination therapy with nab-PTX and CPA was 220 mg/m2 and 600 mg/m2, respectively, in patients with metastatic or recurrent breast cancer.

Keywords

Breast cancer nab-paclitaxel Cyclophosphamide Phase I 

Notes

Conflict of interest

All authors declare no conflicts of interest.

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Copyright information

© Japan Society of Clinical Oncology 2014

Authors and Affiliations

  • Goro Kutomi
    • 1
  • Tousei Ohmura
    • 2
  • Fukino Satomi
    • 1
  • Hideki Maeda
    • 1
  • Hiroaki Shima
    • 1
  • Hidekazu Kameshima
    • 2
  • Minoru Okazaki
    • 3
  • Hideji Masuoka
    • 4
  • Kenichi Sasaki
    • 5
  • Koichi Hirata
    • 1
  1. 1.Department of Surgery, Surgical Oncology and Science, School of MedicineSapporo Medical UniversitySapporoJapan
  2. 2.Department of SurgeryHigashi-Sapporo HospitalSapporoJapan
  3. 3.Sapporo Breast Surgical ClinicSapporoJapan
  4. 4.Sapporo-Kotoni Breast ClinicSapporoJapan
  5. 5.Department of SurgeryMuroran City General HospitalMuroranJapan

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