NCT00268918

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

A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Ovarian Cancer
• Endometrial Cancer
• Cervical Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Participants may continue receiving study drug as long as their disease does not worsen
DRUG	PTK787	Participants may continue receiving study drug as long as their disease does not worsen

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-01-01
• Completion: 2011-01-01
• First posted: 2005-12-23
• Last updated: 2018-07-27

Locations

2 sites across 1 country: United States