A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 241
- Primary Endpoint
- Quality-adjusted survival
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tamoxifen
Tamoxifen 40 mg is given orally once daily until progression
Intervention: Tamoxifen (Drug)
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
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Quality-adjusted survival
Time Frame: through completion of study, on average 1 year
Secondary Outcomes
- progression-free survival(through completion of study, on average 3 months)
- overall survival(through completion of study, on average 1 year)