A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
Susana M. Campos, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|