Phase II trial evaluating the efficacy and safety of physician chosen chemotherapy with hormonal therapy in patients with heavily pretreated advanced ovarian cancer: A multicenter pilot study

Not Applicable

Active, not recruiting

Conditions: Neoplasms

Registration Number: KCT0004571

Lead Sponsor: Inha University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 58

Inclusion Criteria

=19 age
- Patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC): including all histologic types
-Confirmation of recurrence using biopsy from primary or metastatic tissue
-Palliative treatment setting: [(previous progression free or treatment free interval < 6months and 2 prior chemotherapy regimens) or (=3 prior chemotherapy regimens)]
-ECOG Performance status 0-2
-Measurable lesion
- Estimated life time =6months
- Adequate hematologic and end organ function
- During clinical trial, women of reproductive age should undergo adequate contraception, and should not perform breast feeding. Moreover, women should have negative pregnancy test performed immediately before clinical trial

Exclusion Criteria

-Patients who were diagnosed with other type of primary cancer within 5 years from diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC): except cervical intraepithelial neoplasm
-Cases that investigator decides as inadequate for study
-Patient who has not been recovered from recent surgery
-Patient having toxicity more than grade 2 of CTCAE originated from previous chemotherapy
-Patient receiving immunotherapy or targeted therapy as anticancer therapy
-History of venous thromboembolism
-Pregnant women or women having possibility of pregnancy
-Hypersensitivity for tamoxifen
-Patient receiving combined therapy with Anstrozole
-Patient having genetic disorders such as galactose intolerance, lapp lactase deficiency or glucose-galactose malaborption
-Hypersensitivity for megestrol acetate

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective response rate

Secondary Outcome Measures

Name	Time	Method
discordance in hormonal receptor expression between tissues obtained from biopsies at enrollment and at time of disease progression;methylation status of hormonal receptors;Adverse events