Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma - Full Text View

Purpose

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

Condition	Intervention	Phase
Breast Neoplasms	Drug: Oxaliplatin Drug: vinorelbine	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Vinorelbine Vinorelbine tartrate Oxaliplatin Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

overall response rate [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]
time to progression (TTP). [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
tolerance [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
toxicity. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403988

Locations


Lebanon
	Sanofi-aventis
	BEIRUT, Lebanon

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Marie-Therese SAWAYA, MD	Sanofi-Aventis

More Information

Study ID Numbers:	L_9116
First Received:	November 23, 2006
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00403988
Health Authority:	Lebanon: Ministry of Public Health