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.