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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Breast Cancer; Ovarian Cancer; Fallopian Tube Cancer; Endometrial Cancer; Peritoneal Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: PTK787

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Massachusetts General Hospital; Brigham and Women's Hospital
• Investigators: Principal Investigator: Susana M. Campos, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 23, 2005

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; PTK787; Refractory gynecological cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Adnexal Diseases; Breast Diseases; Fallopian Tube Diseases; Breast Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Vatalanib
• Other Study ID Numbers: 05-020