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
NCT number | NCT00268918 |
Other study ID # | 05-020 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | September 2005 |
Est. completion date | January 2011 |
Verified date | July 2018 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, Massachusetts General Hospital |
United States,
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 |
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