Clinical trial NCT00758732: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Cancer
Ovarian cancer
Chemotherapy
Docetaxel
Carboplatin
Pegylated doxorubicin
Platinum sensitive
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-09-25
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes:
measure: Toxicity profile
timeFrame: Toxicity assessment on each cycle
measure: Time to tumor progression
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athnes, Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
city: Athens
country: Greece
facility: Department of Medical Oncology, Air Forces Military Hospital of Athens
city: Athens
country: Greece
facility: Medical Oncology Unit, 401 Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dep of Medical Oncology
city: Piraeus
country: Greece
facility: First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
city: Thessaloniki
country: Greece
facility: Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Study officials:
affiliation: Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
name: Christos Emmanouilides, MD
role: PRINCIPAL_INVESTIGATOR
References: