Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-04 @ 12:58 PM
Study NCT ID:
NCT00268918
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2005-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: