Ovarian NeoplasmsPhase 2NCT00539669
TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian
A Phase 2 study testing Docetaxel in people with Ovarian Neoplasms, run by Sanofi at 1 site in South Korea.
Trial summary
Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Docetaxel
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2003to not given
- 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
- Histologically confirmed epithelial ovarian carcinoma. Patients with peritoneal carcinomatosis are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting, and that there is no evidence of a primary fallopian tube cancer (see exclusion criteria).
- Female, aged 18 or over- FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface of the ovary
- Patients with ruptured capsule as the only evidence of stage Ic will not be eligible for entry into the study.
Who cannot join
- ECOG performance status > 2
- Prior treatment with chemotherapy or radiotherapy.
- Patients with, pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study, but should be monitored closely for any deterioration. Efforts should be made to determine by cytological analysis whether any significant pre-existing fluid collections are due to ovarian cancer, and subsequent drainage is recommended before initiating chemotherapy.
- Inadequate bone marrow function defined as neutrophils < 1.5 x 109/l or platelets < 100 x 109/l.
- Inadequate renal function as defined by serum creatinine > 1.25 x upper limit of normal.
- Inadequate liver function as defined by bilirubin > upper limit of normal or AST/ALT > 1.5 x upper limit of normal or ALP > 3 x upper limit of normal.
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- Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure)
- Patients with mixed mesodermal tumours.
- Patients with borderline ovarian tumours or tumours termed 'possibly malignant'.
- Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer or thought to be possible primary fallopian tube carcinoma.
- History of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concurrent malignancy (e.g. coexisting endometrial cancer) .
- History of prior serious allergic reactions (e.g. anaphylactic shock).
- History of other relative contraindications to corticosteroid administration
- Pregnant or lactating women (or potentially fertile women not using adequate contraception).
- Symptomatic peripheral neuropathy > NCIC-CTC grade II.
- 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.
About this study
Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population.
- Conditions
- Ovarian Neoplasms
- Being tested
- Docetaxel
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyang Rim Kim, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539669
- Sponsor's protocol ID
- XRP6976I_2502
- Status last verified
- Oct 2007
- First submitted
- 3 Oct 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAX + Carboplatin or Cisplatin 1st Line Post-Surgery Ovarian
- ClinicalTrials.gov ID
- NCT00539669
- Acronym / sponsor ID
- XRP6976I_2502
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 4 Oct 2007 (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.
Evaluate response rate of Docetaxel in combination with Carboplatin or Cisplatin as first line chemotherapy in epithelial ovarian cancer. Assess the progression free survival, tolerance, duration of response and survival in the same patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (3 listed)
- Histologically confirmed epithelial ovarian carcinoma. Patients with peritoneal carcinomatosis are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting, and that there is no evidence of a primary fallopian tube cancer (see exclusion criteria).
- Female, aged 18 or over- FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface of the ovary
- Patients with ruptured capsule as the only evidence of stage Ic will not be eligible for entry into the study.
Key exclusion criteria (16 listed)
- ECOG performance status > 2
- Prior treatment with chemotherapy or radiotherapy.
- Patients with, pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study, but should be monitored closely for any deterioration. Efforts should be made to determine by cytological analysis whether any significant pre-existing fluid collections are due to ovarian cancer, and subsequent drainage is recommended before initiating chemotherapy.
- Inadequate bone marrow function defined as neutrophils < 1.5 x 109/l or platelets < 100 x 109/l.
- Inadequate renal function as defined by serum creatinine > 1.25 x upper limit of normal.
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 |
|---|---|---|
| Docetaxel | Drug | – |
Primary outcome
The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated.
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 4 Oct 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.
Hyang Rim Kim study director
Sanofi
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 Docetaxel in people with Ovarian Neoplasms, run by Sanofi at 1 site in South Korea.
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 3 inclusion and 16 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 4 Oct 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 South Korea. 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?
The response rate will be determined by the number of patients with complete and partial responses according to the Modified SWOG Response Criteria. The progression free survival, duration of response and survival are evaluated.. 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 4 Oct 2007.