Status:
COMPLETED
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
* Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00268918
Start Date
September 1 2005
End Date
January 1 2011
Last Update
July 27 2018
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115