EUCTR2004-004880-31-DEActive, not recruitingNot Applicable
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
German Breast Group Forschungs GmbH0 sites60 target enrollmentStarted: December 8, 2004Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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 radiology and tumour 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 haemoglobin =9g/dl
- •Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase = 5x upper normal limit
- •Creatinine = 2.0mg/dl
- •Normal left ventricular ejection fraction (LVEF) by echocardiogramme
- •Patients with childbearing potential, pregnancy test must be negative
- •If fertile effective contraception must be used throughout the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Known 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
- •Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)
- •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
Investigators
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