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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00268918

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Endometrial Cancer Cervical Cancer Fallopian Tube Cancer Peritoneal Cancer Breast Cancer	Drug: Docetaxel Drug: PTK787	Phase 1

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

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Docetaxel / PTK787 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. PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.	Drug: Docetaxel Participants may continue receiving study drug as long as their disease does not worsen Other Names: Taxotere Drug: PTK787 Participants may continue receiving study drug as long as their disease does not worsen Other Names: Vatalanib

Arm

Intervention/Treatment

Experimental: Docetaxel / PTK787

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. PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.

Drug: Docetaxel

Participants may continue receiving study drug as long as their disease does not worsen

Other Names:

Taxotere

Drug: PTK787

Participants may continue receiving study drug as long as their disease does not worsen

Other Names:

Vatalanib

Outcome Measures

Primary Outcome Measures

To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787. [2 years]

Secondary Outcome Measures

To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.