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

September 25, 2015 updated by: Hellenic Oncology Research Group

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • "IASO" General Hospital of Athnes, Dep of Medical Oncology
      • Athens, Greece
        • Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
      • Athens, Greece
        • Department of Medical Oncology, Air Forces Military Hospital of Athens
      • Athens, Greece
        • Medical Oncology Unit, 401 Military Hospital of Athens
      • Larissa, Greece
        • State General Hospital of Larissa, Dep of Medical Oncology
      • Piraeus, Greece
        • First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
      • Thessaloniki, Greece
        • Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
      • Thessaloniki, Greece
        • Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Docetaxel/carboplatin
Drug: Docetaxel
Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Other Names:
  • Taxotere
Drug: Carboplatin
Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Drug: Docetaxel
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.
Other Names:
  • Taxotere
Experimental: 2
Docetaxel/Caelyx
Drug: Docetaxel
Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Other Names:
  • Taxotere
Drug: Docetaxel
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.
Other Names:
  • Taxotere
Drug: Liposomal doxorubicin
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.
Other Names:
  • Caelyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Toxicity profile
Time Frame: Toxicity assessment on each cycle
Toxicity assessment on each cycle
Time to tumor progression
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Christos Emmanouilides, MD, Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/05.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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