Ovarian NeoplasmsOCSTUDNCT00452985
Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
An observational study of Ovarian Neoplasms, run by Sanofi at 1 site in Bangladesh.
Trial summary
Primary objective: To assess response rate. To record the clinical improvement in relation to stage and histopathological grading. Secondary objective: To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen. Read more about this study
- Who is it for?
- Ages 15 to 75 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2002to Nov 2010
- Phase
- Observational
- 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 15 to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced or metastatic ovarian cancer
Who may be able to join
- Performance status Karnofsky index ≥ 60%.
- Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan.
- Histologically: epithelial/germ cell
- Haematology: absolute neutrophil count: ≥2X10^9/L; Platelet: ≥150X10^9/L; Haemoglobin: ≥ 10g/dL
- Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase \& Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
- Renal function: Creatinine: ≤130 µmol/L; If creatinine > 130 µmol/L, the 24 hour creatinine clearance should be > 60 ml/min.
Who cannot join
- Symptomatic peripheral neuropathy > grade 1 by National Cancer Institute - Common Toxicity Criteria scale
- Uncontrolled diabetes mellitus and uncontrolled hypertension
- Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception).
- Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment.
- 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
Official title: Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
Primary objective:
To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.
Secondary objective:
To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.
- Conditions
- Ovarian Neoplasms
- Being tested
- Docetaxel, Carboplatin
- 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
60-75 mg/m²
CarboplatinDrug
AUC 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | * Injection of Docetaxel
* 3-hour gap
* Injection of carboplatin Receives: Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the disease (assessed clinically and/or by CA-125)
Measured: At baseline and from administration of drug to end of treatment
Response rate
Measured: From start to end of treatment
Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
Measured: From the beginning to the end of study
Adverse events
Measured: From the beginning to the end of the study
Secondary outcomes (3)
Progression free survival
Measured: From administration of drug up to end of study
Overall survival
Measured: From administration of drug to end of study
Biology and Hematology laboratory determinations
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 2002
- Primary completionNov 2010
- Study completionNov 2010
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rezaul-Farid Khan, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452985
- Sponsor's protocol ID
- TAX_BD1_601
- Acronym
- OCSTUD
- Status last verified
- Aug 2012
- First submitted
- 27 Mar 2007
- Last updated
- 14 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00452985
- Acronym / sponsor ID
- OCSTUD / TAX_BD1_601
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Mar 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.
Primary objective:
To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.
Secondary objective:
To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Docetaxel, Drug: Carboplatin* Injection of Docetaxel * 3-hour gap * Injection of carboplatin |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced or metastatic ovarian cancer
Key inclusion criteria (6 listed)
- Performance status Karnofsky index ≥ 60%.
- Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan.
- Histologically: epithelial/germ cell
- Haematology: absolute neutrophil count: ≥2X10^9/L; Platelet: ≥150X10^9/L; Haemoglobin: ≥ 10g/dL
- Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase \& Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
Key exclusion criteria (5 listed)
- Symptomatic peripheral neuropathy > grade 1 by National Cancer Institute - Common Toxicity Criteria scale
- Uncontrolled diabetes mellitus and uncontrolled hypertension
- Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception).
- Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Docetaxel60-75 mg/m² | Drug | 1 |
| CarboplatinAUC 5 | Drug | 1 |
Primary outcome
Measurements of the disease (assessed clinically and/or by CA-125)
Time frame: At baseline and from administration of drug to end of treatment
Response rate
Time frame: From start to end of treatment
Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
Time frame: From the beginning to the end of study
Adverse events
Time frame: From the beginning to the end of the study
3 secondary outcomes
Progression free survival
Time frame: From administration of drug up to end of study
Overall survival
Time frame: From administration of drug to end of study
Biology and Hematology laboratory determinations
Time frame: From the beginning to the end of the study
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 14 Aug 2012.
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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.
Rezaul-Farid Khan, Dr study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Sanofi at 1 site in Bangladesh.
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 6 inclusion and 5 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 14 Aug 2012. 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 Bangladesh. 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.
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?
Measurements of the disease (assessed clinically and/or by CA-125) (time frame: At baseline and from administration of drug to end of treatment). The study lists 4 primary outcomes in all. 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 14 Aug 2012.