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)

August 31, 2011 updated by: German Breast Group
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ribomustine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
end of cycle 2 of the 6th patient of the assumed highest dose level

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the objective response rate (phase II part)
Time Frame: EOT last patient (phase II part)
EOT last patient (phase II part)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Breast Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBG 38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on Bendamustine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe