Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

Detailed Description
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The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.

Official Title
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Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: carboplatin
* Drug: paclitaxel
* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV Indication for chemotherapy Age > 18 years Life expectancy of at least 3 months Exclusion Criteria: Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher) Performance Status (ECOG) > or = 3. Previous chemotherapy Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) Neutrophils < 2000 x mm3, platelets < 100000 x mm3 Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values) Present or suspected hemorrhagic syndromes Inability to comply with protocol and follow-up Inability to access study site for clinical visits Refusal of informed consent

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>weekly chemotherapy | Drug: carboplatin<br>* AUC 2 IV every week<br>Drug: paclitaxel<br>* 60mg/m2 IV every week<br>|
| Active Comparator: B<br>every 3 weeks chemotherapy | Procedure: carboplatin<br>* AUC 6 IV day 1 every 21 days<br>Drug: paclitaxel<br>* 175 mg/m2 IV day 1 every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy | 
| progression free survival |  | every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months | 
| response rate |  | after 9 and 18 weeks of therapy | 
| toxicity |  | weekly during therapy | 
| describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis |  | at study entry | 
| describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) |  | at study entry | 
| describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' |  | at study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, weekly therapy, neurotoxicity