Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
NCT ID: NCT02728622
Last Updated: 2016-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2002-03-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamoxifen
Tamoxifen 40 mg is given orally once daily until progression
Tamoxifen
endocrine treatment
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
Chemotherapy
Paclitaxel or pegylated liposomal doxorubicin
Interventions
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Tamoxifen
endocrine treatment
Chemotherapy
Paclitaxel or pegylated liposomal doxorubicin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Nordic Society of Gynaecological Oncology - Clinical Trials Unit
OTHER
Responsible Party
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Principal Investigators
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Gunnar B Kristensen, Prof
Role: STUDY_CHAIR
The Norwegian Radium Hospital, Oslo University Hospital
Other Identifiers
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NSGO-OC-0101
Identifier Type: -
Identifier Source: org_study_id
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