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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268918
• Other study ID #: 05-020
• Status: Completed
• Phase: Phase 1
• Start date: September 2005
• Est. completion date: January 2011

Study information

• Verified date: July 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Docetaxel
Participants may continue receiving study drug as long as their disease does not worsen
• PTK787
Participants may continue receiving study drug as long as their disease does not worsen

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.		2 years
Secondary	To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.		2 years