Ovarian CancerPhase 2NCT00189579
Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
A Phase 2 study testing Herceptin in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Herceptin
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older; patients with histologically proven diagnosis of ovarian cancer.
- Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry)
- Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel.
- Patients who have received at minimum one line of chemotherapy
- 3 weeks minimum since last treatment with chemotherapy must have elapsed
- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 > 1.25 x upper limit of normal (ULN)
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- Patients must have ECOG of 2 or less
- Left ventricular ejection fraction (LVEF) of 50% or better
- Patients have given their signed and verbal consent
Who cannot join
- Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa)
- Another experimental treatment in the previous 30 days
- No overexpression of HER2 receptors
- Patients having received high-dose chemotherapy or stem-cell interventions
- Other cancers within the last 5 years
- Patients with dyspnea at rest or requiring oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel
The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.
- Conditions
- Ovarian Cancer
- Being tested
- Herceptin
- Keywords
- HERCEPTIN, Carboplatin, Paclitaxel, Relapse
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerceptinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Eric Pujade-Lauraine, MD, PhD, Study chair, Hopital Hotel-Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189579
- Sponsor's protocol ID
- TCHERCEPTIN1
- Status last verified
- Aug 2007
- First submitted
- 12 Sep 2005
- Last updated
- 17 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel
- ClinicalTrials.gov ID
- NCT00189579
- Acronym / sponsor ID
- TCHERCEPTIN1
- Conditions
- Ovarian Cancer
- Keywords
- HERCEPTIN, Carboplatin, Paclitaxel, Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older; patients with histologically proven diagnosis of ovarian cancer.
- Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry)
- Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel.
- Patients who have received at minimum one line of chemotherapy
- 3 weeks minimum since last treatment with chemotherapy must have elapsed
Key exclusion criteria (6 listed)
- Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa)
- Another experimental treatment in the previous 30 days
- No overexpression of HER2 receptors
- Patients having received high-dose chemotherapy or stem-cell interventions
- Other cancers within the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herceptin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Pujade-Lauraine, MD, PhD study chair
Hopital Hotel-Dieu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herceptin in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
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 6 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 17 Aug 2007. 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 France. 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. 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.
Where can I read the original study information?
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 17 Aug 2007.