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

NCT ID: NCT02026921

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-12-31

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.

Conditions

Ovarian Epithelial Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin and docetaxel

Intravenous infusion every 3 weeks Carboplatin plus docetaxel

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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.

Interventions

Carboplatin

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

Intervention Type: DRUG

Docetaxel

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.

Intervention Type: DRUG

Other Intervention Names

Taxotere

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar B Kristensen, MD, PhD

Role: STUDY_CHAIR

NSGO-CTU

Locations

Aalborg University Hospital

Aalborg, , Denmark

Herlev University Hospital

Copenhagen, , Denmark

Tampere University Hospital

Tampere, , Finland

Norwegian Radium Hospital

Oslo, , Norway

Countries

Denmark; Finland; Norway

Other Identifiers

NSGO-OC-0303

Identifier Type: -

Identifier Source: org_study_id