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

NCT00403988 | Terminated Phase 2

• 1 other identifier: L_9116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• overall response rate

  During the Study Conduct

• time to progression (TTP).

  during the study conduct

Secondary Outcomes (3)

• survival

  During the study conduct

• tolerance

  During the study conduct

• toxicity.

  During the study conduct

Interventions

Oxaliplatin DRUG

vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Sanofi: collaborator

Study Sites (1)

AmericanUBMC

Beirut, Lebanon

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Oxaliplatin; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2006
• First Posted: November 27, 2006
• Study Start: June 1, 2004
• Study Completion: December 1, 2007
• Last Updated: November 4, 2008

Record last verified: 2008-08

Locations

LE (1)