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

Metastatic Breast Cancer Clinical Trial

— RiTa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661739
• Other study ID #: GBG 38
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2008
• Last updated: August 31, 2011
• Start date: July 2005
• Est. completion date: May 2011

Study information

• Verified date: September 2010
• Source: German Breast Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
German Breast Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine the objective response rate (phase II part)		EOT last patient (phase II part)	No