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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Carboplatin
* Drug: Docetaxel
* Drug: Liposomal doxorubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, Chemotherapy, Docetaxel, Carboplatin, Pegylated doxorubicin, Platinum sensitive, Cancer