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

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Cancer of the Fallopian Tube

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Tamoxifen

Chemotherapy

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tamoxifen

Chemotherapy

Arm Description

Tamoxifen 40 mg is given orally once daily until progression

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

Outcomes

Primary Outcome Measures

Quality-adjusted survival

Secondary Outcome Measures

progression-free survival

time to progressive disease or death

overall survival

time to death of any cause

Full Information

NCT ID

NCT02728622

First Posted

March 19, 2016

Last Updated

April 4, 2016

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

1. Study Identification

Unique Protocol Identification Number

NCT02728622

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Peritoneal Cancer, Cancer of the Fallopian Tube

Keywords

ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tamoxifen

Arm Type

Experimental

Arm Description

Tamoxifen 40 mg is given orally once daily until progression

Arm Title

Chemotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tamoxifen

Intervention Description

endocrine treatment

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

paclitaxel, pegylated liposomal doxorubicin

Intervention Description

Paclitaxel or pegylated liposomal doxorubicin

Primary Outcome Measure Information:

Title

Quality-adjusted survival

Time Frame

through completion of study, on average 1 year

Secondary Outcome Measure Information:

Title

progression-free survival

Description

time to progressive disease or death

Time Frame

through completion of study, on average 3 months

Title

overall survival

Description

time to death of any cause

Time Frame

through completion of study, on average 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gunnar B Kristensen, Prof

Organizational Affiliation

The Norwegian Radium Hospital, Oslo University Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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