RiTa: 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

Sponsor

German Breast Group (Other)

Overall Status

Completed

CT.gov ID

NCT00661739

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Bendamustine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel. [end of cycle 2 of the 6th patient of the assumed highest dose level]

Secondary Outcome Measures

To determine the objective response rate (phase II part) [EOT last patient (phase II part)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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