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

Phase 3

Completed

• Conditions: Ovarian Cancer; Peritoneal Cancer; Cancer of the Fallopian Tube
• Interventions: Drug: Tamoxifen; Drug: Chemotherapy

• Registration Number: NCT02728622
• Lead Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

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 Timeline

• Study Start: 2002-03
• Primary Completion: 2008-01
• Study Completion: 2009-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-04-04
• Last Update Submitted: 2016-04-04
• Study First Posted: 2016-04-05
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 241

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen	Tamoxifen 40 mg is given orally once daily until progression
Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Quality-adjusted survival	through completion of study, on average 1 year

Secondary Outcome Measures

Name	Time	Method
progression-free survival	through completion of study, on average 3 months	time to progressive disease or death
overall survival	through completion of study, on average 1 year	time to death of any cause