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Ovarian CancerPhase 2NCT00758732

Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma

A Phase 2 study testing Docetaxel, Carboplatin and Liposomal doxorubicin in people with Ovarian Cancer, run by Hellenic Oncology Research Group at 12 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months 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?
Docetaxel, Carboplatin and Liposomal doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
12 sitesGreece
Study dates
Oct 2005to Mar 2011
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 ovarian cancer
  • Stage IIIB/IV
  • Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval > 6 months
  • Presence of two-dimensional measurable disease.
  • Life expectancy of more than 3 months.
  • Age ≥ 18 years.
Show all 10Show fewer
  • Performance status (WHO) 0-2
  • 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
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Other concurrent investigational agents

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

Other trials in Greece

About this study

Official title: A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months

Read the detailed description

The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.

Conditions
Ovarian Cancer
Being tested
Docetaxel, Carboplatin, Liposomal doxorubicin
Keywords
Cancer, Ovarian cancer, Chemotherapy, Docetaxel, Carboplatin, Pegylated doxorubicin, Platinum sensitive
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.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

  • CarboplatinDrug

    Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

  • Liposomal doxorubicinDrug

    Also called Caelyx

    Liposomal doxorubicin at the dose of 20 mg/m2 over a 90 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

Study groups in NCT00758732
Study groupRoleWhat they receive
1ExperimentalDocetaxel/carboplatin
Receives: Drug: Docetaxel; Drug: Carboplatin
2ExperimentalDocetaxel/Caelyx
Receives: Drug: Docetaxel; Drug: Liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary outcomes (3)

  1. Toxicity profile

    Measured: Toxicity assessment on each cycle

  2. Time to tumor progression

    Measured: 1 year

  3. Overall Survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2008 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2011
  4. Study completionMar 2011

Why it stopped: Poor accrual

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00758732
Sponsor's protocol ID
CT/05.09
Status last verified
Sep 2015
First submitted
24 Sep 2008
Last updated
28 Sep 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Carboplatin and Liposomal doxorubicin 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 10 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: stopped early, as of the sponsor's last update on 28 Sep 2015. 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 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 (reason given: Poor accrual). 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.

What does the primary outcome measure?

Overall Response Rate (time frame: 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?

On the ClinicalTrials.gov record for NCT00758732.

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 28 Sep 2015.

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