Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients (NCT00268918) | Clinical Trial Compass
CompletedPhase 1
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
United States24 participantsStarted 2005-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.