Clinical trial NCT00661739: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: palliative
Breast cancer
metastatic
Bendamustine
phase I
Lead sponsor: GBG Forschungs GmbH
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.
timeFrame: end of cycle 2 of the 6th patient of the assumed highest dose level
Secondary outcomes:
measure: To determine the objective response rate (phase II part)
timeFrame: EOT last patient (phase II part)
Other outcomes:
Locations:
Study officials:
References: