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

This study has been terminated.
(The results of a same study design have shown low response with important side effects. Accordingly & ethicly, the study has been stopped.)
Sponsor:
Collaborator:
Sanofi
Information provided by:
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00403988
First received: November 23, 2006
Last updated: November 3, 2008
Last verified: August 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Lebanon
AmericanUBMC
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403988     History of Changes
Other Study ID Numbers: L_9116
Study First Received: November 23, 2006
Last Updated: November 3, 2008
Health Authority: Lebanon: Ministry of Public Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Oxaliplatin
Vinorelbine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 16, 2014