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Phase II Study of Docetaxel Combined With Ketoconazole in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

Phase II Study of Docetaxel Combined With Ketoconazole in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor


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 pathological response rates in metastatic breast cancer. We further hypothesize
that tumor genomic and proteomic changes and serum proteomic changes would correlate with
tumor response. We are also looking to correlate drug pharmacokinetics with treatment
toxicity, genotype of drug metabolizing enzymes and transporters, and peripheral mononuclear
cell gene expression profiles. The primary objectives are to evaluate the clinical response
rate of 70mg docetaxel with ketoconazole in metastatic breast cancer, and to evaluate the
pathological response rate in the primary tumor following four cycles of docetaxel and
ketoconazole.


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. Evaluate the clinical response rate of 70mg docetaxel with ketoconazole in metastatic breast cancer.

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Soo-Chin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Consultant

Authority:

Singapore: Health Sciences Authority

Study ID:

BR01/07/05

NCT ID:

NCT00212095

Start Date:

June 2005

Completion Date:

June 2012

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • docetaxel
  • gene expression
  • proteomics
  • Breast Neoplasms

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