Status:
COMPLETED
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
Lead Sponsor:
GBG Forschungs GmbH
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00661739
Start Date
July 1 2005
End Date
May 1 2011
Last Update
September 2 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.