Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

Study Overview
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Brief Summary
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This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Detailed Description
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Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

Official Title
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Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy Patients have to be chemotherapy naive Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination Age >18 years. Performance status (WHO) 0-2 Life expectancy of at least three months. 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 No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Paclitaxel/Carboplatin | Drug: Paclitaxel<br>* 175 mg/m2, I.V, every 2 weeks<br>Drug: Carboplatin<br>* Carboplatin AUC, I.V, 5 every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose and the response rate |  | Toxicity assestment of the 1st cycle for the first 10 patients. 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Ovarian cancer, Dose-dense chemotherapy