Overview

Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
Female
Summary
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Treatments:
Docetaxel
Vatalanib
Criteria
Inclusion Criteria:

- Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be
confirmed histologically.

- Measurable disease or nonmeasurable disease

- Age > 18 years

- ECOG performance 0,1,2

- 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy

- Certain lab values

- Negative for proteinuria

Exclusion Criteria:

- Four or more treatment regimens

- History or presence of uncontrolled CNS disease

- Prior biologic or immunotherapies less than 3 weeks prior to registration

- Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less
than 2 weeks prior to registration

- Prior therapy with anti-VEGF agents

- Peripheral neuropathy with functional impairment > CTC grade 2

- Pregnant or breast feeding

- Concurrent severe and/or uncontrolled medical condition

- Chronic renal disease

- Acute or chronic liver disease

- Impairment of gastrointestinal function or GI disease

- Confirmed diagnosis of HIV infection are excluded at the investigators discretion

- Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the
cytochrome p450 system.