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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00403988
• Other study ID #: L_9116
• Status: Terminated
• Phase: Phase 2
• First received: November 23, 2006
• Last updated: November 3, 2008
• Start date: June 2004
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Oxaliplatin

• vinorelbine

Locations

Country	Name	City	State
Lebanon	AmericanUBMC	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Sanofi

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		During the Study Conduct	No
Primary	time to progression (TTP).		during the study conduct	No
Secondary	survival		During the study conduct	No
Secondary	tolerance		During the study conduct	No
Secondary	toxicity.		During the study conduct	No