A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer (RiTa)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00661739
First received: April 15, 2008
Last updated: August 31, 2011
Last verified: September 2010
  Purpose

The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Bendamustine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by German Breast Group:

Primary Outcome Measures:
  • The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel. [ Time Frame: end of cycle 2 of the 6th patient of the assumed highest dose level ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the objective response rate (phase II part) [ Time Frame: EOT last patient (phase II part) ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: July 2005
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Singular Arm
Bendamustine treatment
Drug: Bendamustine
Dose-level Bendamustine(mg/m²): I:50; II:60; III:60; IV:70; V:70 Dose-level Paclitaxel (mg/m²): I:60; II:60; III:80; IV:80; V:90 Treatment will be given on day 1,8,15 and repeated on day 29. When the recommended dose has been determined a total of 48 pts will be treated at this dose level.
Other Name: Ribomustine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
  • Pathological confirmed primary carcinoma of the breast.
  • Locally advanced or metastatic disease
  • Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
  • Patients must have either measurable or non-measurable lesions according to the WHO criteria
  • At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
  • Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
  • Karnofsky-Index ≥ 60 %
  • Age ≥ 18 years
  • Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
  • Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
  • Serum creatinine ≤ 2.0 mg/dl
  • Normal left ventricular ejection fraction (LVEF) by echocardiogramme
  • Patients of childbearing potential, pregnancy test must be negative
  • If fertile effective contraception must be used throughout the study

Exclusion Criteria:

  • Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
  • Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
  • Symptomatic parenchymal brain metastases not responding to treatment
  • Life expectancy less than 3 months
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
  • Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days;
  • History of congestive heart failure or other significant uncontrolled cardiac disease
  • Pregnant or nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT00661739     History of Changes
Other Study ID Numbers: GBG 38
Study First Received: April 15, 2008
Last Updated: August 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Breast Group:
palliative
Breast cancer
metastatic
Bendamustine
phase I

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bendamustine
Nitrogen Mustard Compounds
Paclitaxel
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 20, 2014