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

Phase 2

Completed

• Conditions: Ovarian Epithelial Cancer Recurrent
• Interventions: Drug: Carboplatin; Drug: Docetaxel

• Registration Number: NCT02026921
• Lead Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2006-03
• Study Completion: 2008-12
• Status Verified: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin and docetaxel	Carboplatin	Intravenous infusion every 3 weeks Carboplatin plus docetaxel
Carboplatin and docetaxel	Docetaxel	Intravenous infusion every 3 weeks Carboplatin plus docetaxel

Primary Outcome Measures

Name	Time	Method
Safety	Up to 30 days after last chemotherapy course	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Tampere University Hospital; 🇫🇮 Tampere, Finland

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Herlev University Hospital; 🇩🇰 Copenhagen, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark