Status:
COMPLETED
Docetaxel Combined With Ketoconazole in Treatment of Breast Cancer
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Patients with locally advanced or metastatic breast cancer and with measurable primary breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies and plasma sam...
Detailed Description
We hypothesize that 70mg docetaxel co-administered with ketoconazole would result in similar clinical efficacy as conventional doses of docetaxel (75mg/m2 body surface area) in terms of clinical and p...
Eligibility Criteria
Inclusion
- Female, age \>= 18 years.
- Histologic or cytologic diagnosis of breast carcinoma.
- T3-4 breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.
- Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.
- Karnofsky performance status of 70 or higher.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following:
- \- Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L
- \- Hepatic: Bilirubin \<= 1.5 x upper limit of normal (ULN), ALT or AST \<= 2.5x ULN, (or \<5 X with liver metastases)
- \- Renal: creatinine \<= 1.5x ULN
- Left ventricular ejection fraction \>=50%
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion
- Prior treatment for locally advanced or metastatic breast cancer.
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Pregnancy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or dementia.
- Peripheral neuropathy of CTC grade 2 or above (NCI CTC version 3).
- History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00212095
Start Date
June 1 2005
End Date
June 1 2012
Last Update
November 1 2012
Active Locations (1)
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1
National University Hospital
Singapore, Singapore