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
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Quality-adjusted survival
Secondary Outcome
progression-free survival
Condition
Ovarian Cancer
Intervention
Tamoxifen
Study Arms / Comparison Groups
Tamoxifen
Description: Tamoxifen 40 mg is given orally once daily until progression
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
241
Start Date
March 2002
Completion Date
January 2009
Primary Completion Date
January 2008
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gunnar B Kristensen, Prof, ,
Administrative Informations
NCT ID
NCT02728622
Organization ID
NSGO-OC-0101
Responsible Party
Sponsor
Study Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study Sponsor
Gunnar B Kristensen, Prof, Study Chair, The Norwegian Radium Hospital, Oslo University Hospital
Verification Date
March 2016