Clinical trial NCT00403988: Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Official title: A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-11-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Objective :

To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen in patients with Metastatic Breast Cancer


Eligibility criteria: Inclusion Criteria:

* Metastatic, histologically or cytologically proven breast cancer.
* At least one bi-dimensionally measurable lesion.
* Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes.
* Treatment as adjuvant is allowed.
* World Health Organization-ECOG performance status 0-2.
* Adequate renal function (Creatinine \<= 1.4 or Creatinine clearance \>= 30 ml/min)
* Adequate hepatic function (Liver Function Tests not more than 3 times the normal values)
* Adequate bone marrow reserve is required (Neutrophils (PMN) \>= 2000/mm2 and Platelets \>= 100,000/mm2)
* Patient who will receive Herceptin should have an over-expression of HER2-neu.

Exclusion Criteria:

* Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one).
* Pregnant or breast-feeding.
* History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma).
* Receiving or had received, any treatment with experimental drugs.
* Had known brain or leptomeningeal involvement.
* Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %.
* The presence of bone as a sole site of metastasis.
* Radiation therapy to all areas of measurable disease less than four weeks before treatment.
* Creatinine two times above the normal range
* Hypercalcemia
* Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion.
* Concomitant steroid intake for \> 4 weeks
* Bilirubin two times above the normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: overall response rate
timeFrame: During the Study Conduct
measure: time to progression (TTP).
timeFrame: during the study conduct
Secondary outcomes:
measure: survival
timeFrame: During the study conduct
measure: tolerance
timeFrame: During the study conduct
measure: toxicity.
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: AmericanUBMC
Study officials:
References: