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

This study has been withdrawn prior to enrollment.
(Poor accrual)
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00758732
First received: September 24, 2008
Last updated: May 20, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
 Drug: Docetaxel
Drug: Carboplatin
Drug: Liposomal doxorubicin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
  • Time to tumor progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Taxotere
Drug: Carboplatin
Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Experimental: 2
Docetaxel/Caelyx
 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 Name: 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 Name: Caelyx

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758732

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
Medical Oncology Unit, 401 Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
Piraeus, Greece
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Thessaloniki, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Christos Emmanouilides, MD Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
  More Information

No publications provided

Responsible Party: Antonia Kalykaki, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00758732     History of Changes
Other Study ID Numbers: CT/05.09
Study First Received: September 24, 2008
Last Updated: May 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Cancer
Ovarian cancer
Chemotherapy
Docetaxel
 Carboplatin
Pegylated doxorubicin
Platinum sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Docetaxel
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013