Trials / Completed
CompletedNCT00661739
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- GBG Forschungs GmbH · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2010-09-01
- Completion
- 2011-05-01
- First posted
- 2008-04-18
- Last updated
- 2011-09-02
Source: ClinicalTrials.gov record NCT00661739. Inclusion in this directory is not an endorsement.