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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Docetaxel
Liposomal doxorubicin
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer, Ovarian cancer, Chemotherapy, Docetaxel, Carboplatin, Pegylated doxorubicin, Platinum sensitive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Docetaxel/carboplatin

Docetaxel/Caelyx

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Toxicity profile
Time to tumor progression
Overall Survival

Full Information

First Posted
September 24, 2008
Last Updated
September 25, 2015
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00758732
Brief Title
Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Cancer, Ovarian cancer, Chemotherapy, Docetaxel, Carboplatin, Pegylated doxorubicin, Platinum sensitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel/carboplatin
Arm Title
2
Arm Type
Experimental
Arm Description
Docetaxel/Caelyx
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal doxorubicin
Other Intervention Name(s)
Caelyx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
Toxicity assessment on each cycle
Title
Time to tumor progression
Time Frame
1 year
Title
Overall Survival
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Emmanouilides, MD
Organizational Affiliation
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athnes, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
City
Athens
Country
Greece
Facility Name
Department of Medical Oncology, Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Medical Oncology Unit, 401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
Facility Name
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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