FIGO Stage III-IV serous epithelial ovarian carcinoma
Conditions
Sponsors
Tampere University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of FIGO St III-IV serous epithelial ovarian carcinoma. 2. Age 18- 75 years 3. Measurable disease by RECIST criteria or evaluable disease by Ca-125 criteria. 4. ECOG performance status 0-2 5. Lab values in protocol 6.Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first 7.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures 8.Patient must be able to comply with the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study 2. Ongoing anti-neoplastic chemo- or radiotherapy (minimum 4 weeks interval before study inclusion) 3. Previous malignant disease except for cured carcinoma in situ of the cervix or basalioma of skin 4. Borderline tumors 5. Planned radiotherapy for underlying disease 6. Clinical or radiological evidence of CNS metastases 7. Serious non-healing wound or ulcer 8. Bleeding diathesis or coagulopathy 9. Previous or concurrent thromboembolic disease 10. Uncontrolled hypertension 11. Clinically significant active cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 12. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications 13. Ongoing treatment with acetylsalicylic acid (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (e.g. chronic use of non-steroidal anti-inflammatory analgesics) 14. Pregnancy (positive serum pregnancy test) and lactation 15. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint: The expression of VEGF, VEGFR1, and VEGFR2 by serous epithelial ovarian carcinoma ;Primary end point(s): The expression of VEGF, VEGFR1, and VEGFR2 by serous epithelial ovarian carcinoma is the primary end point, and the secondary end point is the response of serous ovarian carcinoma to the therapy with bevacizumab (Avastin), paclitaxel and carboplatin.;Secondary Objective: Secondary endpoints: Response rate of serous epithelial ovarian carcinoma to bevacizumab combined with paclitaxel and carboplatin according to RECIST (and/or Ca-125 criteria) PFS, OS Tertiary endpoints To explore the correlation of tumor VEGF, VEGFR1 and VEGFR2 expression with the clinical efficacy of the treatment To explore the correlation of tumor VEGF, VEGFR1 and VEGFR2 expression with other indicators of metastatic/high risk disease like MMP2, MMP9, TIMP1, TIMP2 | — |
Countries
Finland
Outcome results
None listed