Phase I dose finding study evaluating the combination of bendamustine with weekly paclitaxel in patients with pre-treated metastatic breast cancer: RiTa trial

Cancer Chemotherapy and Pharmacology
S LoiblG von Minckwitz

Abstract

The aim of the RiTa trial is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule in anthracycline pre-treated metastatic breast cancer patients. Starting dose of bendamustine was 50 mg/m(2) and was stepwise increased by 10 mg/m(2) up to 70 mg/m(2). The starting dose of paclitaxel was 60 mg/m(2) and was increased up to 90 mg/m(2). There are five pre-defined dose levels with three patients per dose level (maximum six patients) and six patients in the last dose level according to the Goodman design. Dose-limiting toxicities were defined as severe neutropenia and thrombocytopenia as well as non-haematological toxicities >/=NCI-CTC grade 3 in the first cycle. No dose-limiting toxicity up to 70 mg/m(2) bendamustine and 90 mg/m(2) paclitaxel occurred during the first cycle. Over all cycles, the following severe haematological toxicities (grade 3 and 4) were documented: neutropenia five patients and anaemia one patient. Relevant grade 3 and 4 non-haematological toxicities over all cycles were fatigue two patients, dyspnoea one patient, infection four patients and bone pain in one patient. Five serious adverse events, but no therapy related death occurred. Five patients showed a complete or partial re...Continue Reading

References

Apr 1, 1990·Onkologie·L Edler
Jun 15, 1995·Statistics in Medicine·S N GoodmanS Piantadosi
Dec 22, 1998·Journal of Cancer Research and Clinical Oncology·K HöffkenS Seeber
Dec 27, 1989·Health Services Journal·J Hill
Aug 15, 2000·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P SchöffskiA Ganser
Nov 16, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·E A PerezR Patel
Jun 27, 2002·Breast Cancer Research and Treatment·Edith A PerezRavi Patel
Jan 30, 2004·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·A J ten TijeJ Verweij
Dec 1, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stephen E JonesLina Asmar
Sep 18, 2007·Annals of Oncology : Official Journal of the European Society for Medical Oncology·U ReichmannJ Huober
Jan 4, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Lorenzo M LeoniChristina C Niemeyer

❮ Previous
Next ❯

Citations

Sep 24, 2013·Expert Opinion on Pharmacotherapy·Massimo GentileFortunato Morabito
Sep 14, 2012·Expert Opinion on Drug Metabolism & Toxicology·Anna Korycka-Wołowiec, Tadeusz Robak

❮ Previous
Next ❯

Related Concepts

Related Feeds

Anemia

Anemia develops when your blood lacks enough healthy red blood cells. Anemia of inflammation (AI, also called anemia of chronic disease) is a common, typically normocytic, normochromic anemia that is caused by an underlying inflammatory disease. Here is the latest research on anemia.