Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2005

Last Updated Date

October 30, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.

Change History

Complete list of historical versions of study NCT00268918 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Historical Control
Endpoint Classification:  Safety Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Docetaxel
Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle. Participant can continue receiving study drug as long as disease does not progress.

Other Name: Taxotere
Drug: PTK787
Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day. Participants may continue receiving study drug as long as their disease does not worsen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00268918

Responsible Party

Susana M. Campos, MD, Dana-Farber Cancer Institute

Study ID Numbers ^ICMJE

05-020

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Brigham and Women's Hospital
Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Susana M. Campos, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP