Cancer of the Fallopian Tube, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
ovarian cancer, platinum-resistant, endocrine treatment, chemotherapy, tamoxifen
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).
Interventions
DRUGTamoxifen
endocrine treatment
DRUGChemotherapy
Paclitaxel or pegylated liposomal doxorubicin
Sponsors
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality-adjusted survival | through completion of study, on average 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed