Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

April 4, 2016 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 3

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:

  • Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
  • Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
  • Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
  • Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
  • Age must be at least 18 years.
  • Performance status must be 0-2 (WHO/ECOG, appendix 1).
  • Informed consent given according to ICH/EU GCP guidelines and local or national laws

Exclusion Criteria:

  • Patients with symptomatic brain metastasis
  • Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
  • Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
  • Pregnant, lactating, or child bearing potential patients without adequate contraception
  • Previous treatment with Tamoxifen.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen
Tamoxifen 40 mg is given orally once daily until progression
Drug: Tamoxifen
endocrine treatment
Active Comparator: Chemotherapy
Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression
Drug: Chemotherapy
Paclitaxel or pegylated liposomal doxorubicin
Other Names:
  • pegylated liposomal doxorubicin
  • paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality-adjusted survival
Time Frame: through completion of study, on average 1 year
through completion of study, on average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: through completion of study, on average 3 months
time to progressive disease or death
through completion of study, on average 3 months
overall survival
Time Frame: through completion of study, on average 1 year
time to death of any cause
through completion of study, on average 1 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, Prof, The Norwegian Radium Hospital, Oslo University Hospital

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

March 1, 2002

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 19, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSGO-OC-0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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