Ovarian CancerPhase 1/2NCT00750386
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
A Phase 1/2 study testing Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hellenic Oncology Research Group at 12 sites in Greece.
Trial summary
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesGreece
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 1/2
- 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
- Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
- Patients have to be chemotherapy naive
- Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
- Age >18 years.
- Performance status (WHO) 0-2
- Life expectancy of at least three months.
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- Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3).
- Adequate liver (Bilirubin<1.5 times upper limit of normal and SGOT/SGPT<2 times upper limit of normal) and renal function (creatinine<2mg/dl)
- Informed consent
Who cannot join
- Pregnant or nursing
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Greece12 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
Athens
Department of Medical Oncology, Air Forces Military Hospital of Athens
Athens
Medical Oncology Unit, 401 Military Hospital of Athens
Athens
University Hospital of Crete
Heraklion, Crete, 71110
State General Hospital of Larissa, Dep of Medical Oncology
Larissa
First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Thessaloniki
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.
Read the detailed description
Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.
- Conditions
- Ovarian Cancer
- Being tested
- Paclitaxel, Carboplatin
- Keywords
- Cancer, Ovarian cancer, Dose-dense chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
175 mg/m2, I.V, every 2 weeks
CarboplatinDrug
Carboplatin AUC, I.V, 5 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Paclitaxel/Carboplatin Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose and the response rate
Measured: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (2)
Toxicity profile
Measured: Toxicity assessment on each cycle
Time to tumor progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Christos Emmanouilides, MD, Principal investigator, Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750386
- Sponsor's protocol ID
- CT/07.07
- Status last verified
- May 2011
- First submitted
- 9 Sep 2008
- Last updated
- 23 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00750386
- Acronym / sponsor ID
- CT/07.07
- Conditions
- Ovarian Cancer
- Keywords
- Cancer, Ovarian cancer, Dose-dense chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Sep 2008 (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.
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.
Detailed description
Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Paclitaxel, Drug: CarboplatinPaclitaxel/Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
- Patients have to be chemotherapy naive
- Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
- Age >18 years.
- Performance status (WHO) 0-2
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
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 |
|---|---|---|
| Paclitaxel175 mg/m2, I.V, every 2 weeks | Drug | 1 |
| CarboplatinCarboplatin AUC, I.V, 5 every 2 weeks | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose and the response rate
Time frame: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
2 secondary outcomes
Toxicity profile
Time frame: Toxicity assessment on each cycle
Time to tumor progression
Time frame: 1 year
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 23 May 2011.
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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.
Christos Emmanouilides, MD principal investigator
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hellenic Oncology Research Group at 12 sites in Greece.
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 4 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 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the maximum tolerated dose and the response rate (time frame: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)). 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 23 May 2011.