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
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 1
Study Type
Interventional
Primary Outcome
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
Secondary Outcome
To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
Condition
Ovarian Cancer
Intervention
Docetaxel
Study Arms / Comparison Groups
Docetaxel / PTK787
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.
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
Drug
Estimated Enrollment
24
Start Date
September 2005
Completion Date
January 2011
Primary Completion Date
January 2007
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Susana M. Campos, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00268918
Organization ID
05-020
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
Study Sponsor
Susana M. Campos, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
July 2018