A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

Study Overview
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Brief Summary
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A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer. Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Detailed Description
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Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Official Title
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A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer

Conditions
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Ovarian Epithelial Cancer Recurrent

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin. Female age above 18 years WHO performance status 0-2 Life expectancy > 3 months Previous treatment with one platinum and taxane containing regimen. Platinum and taxane sensitive relapse At least one evaluable/measurable lesion. Adequate hematologic, renal and liver function Consent form signed and dated before inclusion Exclusion Criteria: Prior treatment with more than one line of chemotherapy Concurrent severe and/or uncontrolled co-morbid medical condition. History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock Pregnant or lactating women (or potentially fertile women not using adequate contraception) Peripheral neuropathy > Grade 2 History of allergy to drugs containing the excipient TWEEN 80®. Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy Clinical evidence of brain metastases

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin and docetaxel<br>Intravenous infusion every 3 weeks Carboplatin plus docetaxel | Drug: Carboplatin<br>* Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops<br>Drug: Docetaxel<br>* 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included. | Up to 30 days after last chemotherapy course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR. | Up to 30 dayes after last chemotherapy course | 
| Progression free survival | Time from start of treatment to the earlier date of assessment of progression or death by any cause. | Up to 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxicity, Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin