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

December 31, 2013 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Copenhagen, Denmark, 2730
        • Herlev University Hospital
  • Finland
      • Tampere, Finland
        • Tampere University Hospital
  • Norway
      • Oslo, Norway, 0310
        • Norwegian Radium Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carboplatin and docetaxel
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
Drug: 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
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.
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 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.
Up to 30 days after last chemotherapy course

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 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.
Up to 30 dayes after last chemotherapy course
Progression free survival
Time Frame: Up to 3 year
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
Up to 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Investigators

  • Study Chair: Gunnar B Kristensen, MD, PhD, NSGO-CTU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSGO-OC-0303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe