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Breast NeoplasmsPhase 2NCT00403988

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

A Phase 2 study testing Oxaliplatin and vinorelbine in people with Breast Neoplasms, run by American University of Beirut Medical Center at 1 site in Lebanon.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Oxaliplatin and vinorelbine
How many people
40 participants
Where
1 siteLebanon
Study dates
Jun 2004to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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 %.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • AmericanUBMC

    Beirut

Other trials in Lebanon

About this study

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

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

Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

    Measured: During the Study Conduct

  2. time to progression (TTP).

    Measured: during the study conduct

Secondary outcomes (3)

  1. survival

    Measured: During the study conduct

  2. tolerance

    Measured: During the study conduct

  3. toxicity.

    Measured: During the study conduct

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2006 (estimated)
  2. Study startJun 2004
  3. Study completionDec 2007

Why it stopped: The results of a same study design have shown low response with important side effects. Accordingly \& ethicly, the study has been stopped.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403988
Sponsor's protocol ID
L_9116
Status last verified
Aug 2008
First submitted
23 Nov 2006
Last updated
4 Nov 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin and vinorelbine in people with Breast Neoplasms, run by American University of Beirut Medical Center at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The results of a same study design have shown low response with important side effects. Accordingly \& ethicly, the study has been stopped.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: During the Study Conduct). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00403988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2008.

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