Status:
COMPLETED
A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
MDS Pharma Services
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor respons...
Eligibility Criteria
Inclusion
- Patients must fulfill all the following criteria:
- Females aged 18 to 70 years-old.
- Willingness to participate in the study and comply with its procedures.
- Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).
- No prior chemotherapy for metastatic breast cancer.
- Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:
- patients treated with anthracyclines if all the following conditions are met:
- Doxorubicin total dose \<= 300 mg/m\^2
- Epirubicin total dose \<= 480 mg/m\^2
- Chemotherapy-free interval of \> 12 months
- no taxane-based adjuvant or neo-adjuvant chemotherapy is allowed;
- patients treated with non-anthracycline/taxane adjuvant or neo-adjuvant chemotherapy regimens are freely eligible (i.e. cyclophosphamide/methotrexate/fluorouracil (CMF) or similar regimens).
- At least one measurable lesion according to RECIST criteria.
- Complete hematologic and biologic baseline evaluation within 2 weeks prior to start of treatment.
- Complete Tumor baseline evaluation including a total body computed tomography (CT) scan within 4 weeks prior to start of treatment.
- Left ventricular ejection fraction (LVEF) \>= 50% as determined by echocardiogram or Multi Gated Acquisition (MUGA) scan.
- World Health Organization (WHO) performance status 0,1.
- Life expectancy \> 3 months.
- Laboratory requirements :
- Hematology :
- Neutrophils \> 1.5 x 10\^9/L
- Platelets \> 100 x 10\^9/L
- Hemoglobin \> 10 g/dL
- Hepatic function:
- Total bilirubin \<= 1.25 x the upper-normal limits (UNL);
- ASAT (Aspartate Aminotransferase or SGOT), ALAT (Alanine aminotransferase or SGPT) \<= 2.5 x the upper-normal limits;
- For patients with liver metastases:
- Total bilirubin \< 1.5 x the UNL (Upper limit of normal) ;
- ASAT and/or ALAT \< 3 x the UNL;
- Renal function :
- Serum Creatinine \< 1.5 x the UNL.
- Women of child bearing potential must have a negative serum pregnancy test and be using adequate contraception.
- Patients must be accessible for treatment and follow-up.
Exclusion
- Patients will not be enrolled if any of the following criteria apply:
- Prior chemotherapy for metastatic disease.
- History of prior malignancy in the last 10 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).
- Radiation to disease areas within 3 weeks of study initiation.
- Symptomatic peripheral neuropathy \> grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.
- Other serious illness or medical condition.
- LVEF \< 50% as determined by echocardiogram or MUGA scan.
- Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active infection.
- Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Concurrent treatment with corticosteroids used for reasons other than for premedication. However patients receiving chronic treatment with corticosteroids (\> 6 months) at low dose (\< 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible.
- Taxane-based adjuvant or neo-adjuvant chemotherapy \< 12 months.
- Other concurrent chemotherapy, immunotherapy, radiotherapy or any other investigational medication, for the treatment of the tumor.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
July 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00687440
Start Date
July 15 2005
End Date
October 24 2008
Last Update
July 3 2018
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