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

Study Overview
=================
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).

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

Conditions
-----------------
Ovarian Cancer, Peritoneal Cancer, Cancer of the Fallopian Tube

Intervention / Treatment
-----------------
* Drug: Tamoxifen
* Drug: Chemotherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen<br>Tamoxifen 40 mg is given orally once daily until progression | Drug: Tamoxifen<br>* endocrine treatment<br>|
| Active Comparator: Chemotherapy<br>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<br>* Paclitaxel or pegylated liposomal doxorubicin<br>* Other names: pegylated liposomal doxorubicin;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | time to progressive disease or death | through completion of study, on average 3 months | 
| overall survival | time to death of any cause | through completion of study, on average 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen