Back to resultsVinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Primary Purpose
Breast Neoplasms
Status
Terminated
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Oxaliplatin
vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
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.
Sites / Locations
- AmericanUBMC
Outcomes
Primary Outcome Measures
overall response rate
time to progression (TTP).
Secondary Outcome Measures
survival
tolerance
toxicity.
Full Information
NCT ID
NCT00403988
First Posted
November 23, 2006
Last Updated
November 3, 2008
Sponsor
American University of Beirut Medical Center
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00403988
Brief Title
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
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
The results of a same study design have shown low response with important side effects. Accordingly & ethicly, the study has been stopped.
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
American University of Beirut Medical Center
Collaborators
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
During the Study Conduct
Title
time to progression (TTP).
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
survival
Time Frame
During the study conduct
Title
tolerance
Time Frame
During the study conduct
Title
toxicity.
Time Frame
During the study conduct
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
AmericanUBMC
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
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