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

Brief Title

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

Official Title

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

Brief Summary

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

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Quality-adjusted survival

Secondary Outcome

 progression-free survival

Condition

Ovarian Cancer

Intervention

Tamoxifen

Study Arms / Comparison Groups

 Tamoxifen

Description:  Tamoxifen 40 mg is given orally once daily until progression

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 2002

Completion Date

January 2009

Primary Completion Date

January 2008

Eligibility Criteria

        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.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gunnar B Kristensen, Prof, ,

Administrative Informations

NCT ID

NCT02728622

Organization ID

NSGO-OC-0101

Responsible Party

Sponsor

Study Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Study Sponsor

Gunnar B Kristensen, Prof, Study Chair, The Norwegian Radium Hospital, Oslo University Hospital

Verification Date

March 2016