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A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
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.
* 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 and the evening of receiving chemotherapy. * The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787. * After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22. * Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study. * Patients should not eat grapefruit or drink grapefruit juice during this study.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
September 1, 2005
Primary Completion Date
January 1, 2007
Completion Date
January 1, 2011
Last Updated
July 27, 2018
24
ACTUAL participants
Docetaxel
DRUG
PTK787
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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