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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00661739
Other study ID # GBG 38
Secondary ID
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


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
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