Ovarian CancerPhase 2NCT00231075
Evaluation of the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III-IV
A Phase 2 study testing Paraplatin and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 2 sites in France.
Trial summary
Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paraplatin and Paclitaxel
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2001to May 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
- Patient aged > 70 years
- Neutrophil polynuclears > 1500/mm3 and Platelets > 100 000/mm3
- No clinical icterus
- Life expectancy of at least 3 months
Who cannot join
- Previous diagnosis of malignancy
- Previous chemotherapy treatment
- Previous radiotherapy
- Hypersensitivity to products containing Cremophore EL
- Hepatic values: bilirubine > 2*LSN, SGOT-SGPT > 2*LSN and/or Alkalin phosphatase > 3*LSN
- Myocardiopathy with arrhythmia
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hosptalier Emile Roux
Eaubonne, 95600
Centre Hospitalier Lyon-sud
Pierre-Bénite, 69495
About this study
Official title: National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2
Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.
Read the detailed description
The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.
- Conditions
- Ovarian Cancer
- Being tested
- Paraplatin, Paclitaxel
- Keywords
- Epithelial ovary cancer F.I.G.O. stages III or IV, 70 years or older
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParaplatinDrug
PaclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
Secondary outcomes (5)
Toxicity assessment
Overall survival
Progression-free survival
Rate of response
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJan 2001
- Study completionMay 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
- 75 participants
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Gilles Freyer, MD, PhD, Principal investigator, Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231075
- Sponsor's protocol ID
- FAG-2
- Status last verified
- Sep 2005
- First submitted
- 30 Sep 2005
- Last updated
- 3 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2
- ClinicalTrials.gov ID
- NCT00231075
- Acronym / sponsor ID
- FAG-2
- Conditions
- Ovarian Cancer
- Keywords
- Epithelial ovary cancer F.I.G.O. stages III or IV, 70 years or older
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- May 2007
- First posted
- 4 Oct 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.
Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.
Detailed description
The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
- Patient aged > 70 years
- Neutrophil polynuclears > 1500/mm3 and Platelets > 100 000/mm3
- No clinical icterus
- Life expectancy of at least 3 months
Key exclusion criteria (6 listed)
- Previous diagnosis of malignancy
- Previous chemotherapy treatment
- Previous radiotherapy
- Hypersensitivity to products containing Cremophore EL
- Hepatic values: bilirubine > 2*LSN, SGOT-SGPT > 2*LSN and/or Alkalin phosphatase > 3*LSN
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 |
|---|---|---|
| Paraplatin | Drug | – |
| Paclitaxel | Drug | – |
Primary outcome
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
5 secondary outcomes
Toxicity assessment
Overall survival
Progression-free survival
Rate of response
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2005.
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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.
Gilles Freyer, MD, PhD principal investigator
Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paraplatin and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 2 sites 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 5 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: finished, as of the sponsor's last update on 3 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility). It is what the study was designed to measure, not a finding.
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 3 Nov 2005.