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

Primary Purpose

Ovarian Cancer, Endometrial Cancer, Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
PTK787
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring PTK787, Metastatic breast cancer, Refractory gynecological cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel / PTK787

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2005
Last Updated
July 26, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00268918
Brief Title
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
Official Title
A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer
Keywords
PTK787, Metastatic breast cancer, Refractory gynecological cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel / PTK787
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Participants may continue receiving study drug as long as their disease does not worsen
Intervention Type
Drug
Intervention Name(s)
PTK787
Other Intervention Name(s)
Vatalanib
Intervention Description
Participants may continue receiving study drug as long as their disease does not worsen
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana M. Campos, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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