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

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00403988
Collaborator
Sanofi (Industry)
40
Enrollment
1
Location
42
Duration (Months)
1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2004
Actual Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

  1. overall response rate [During the Study Conduct]

  2. time to progression (TTP). [during the study conduct]

Secondary Outcome Measures

  1. survival [During the study conduct]

  2. tolerance [During the study conduct]

  3. toxicity. [During the study conduct]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 AmericanUBMC Beirut Lebanon

Sponsors and Collaborators

  • American University of Beirut Medical Center
  • Sanofi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00403988
Other Study ID Numbers:
  • L_9116
First Posted:
Nov 27, 2006
Last Update Posted:
Nov 4, 2008
Last Verified:
Aug 1, 2008
Additional relevant MeSH terms:
Breast Neoplasms
Oxaliplatin
Vinorelbine

Study Results

No Results Posted as of Nov 4, 2008