Objective Response Rate
Conditions
Keywords
epithelial ovarian cancer, platinum-resistant recurrent, Abraxane, Bevacizumab Biosimilar
Brief summary
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
Interventions
DRUGalbumin-bound paclitaxe combined with bevacizumab biosimilar
albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
Sponsors
Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy 2. Patients had received at least one prior line of platinum-based chemotherapy 3. Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG 4. Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1 5. life expectancy ≥3 months 6. ≥30 days after surgery, the body has recovered and there is no active infection 7. Patients had received at least 1 prior line of platinum-based chemotherapy and were recurrent or progressed within 6 months after the end of the last platinum-based regimen 8. Must have adequate hematologic and hepatic function 9. Subjects of childbearing age must agree to use effective contraception during the trial period and negative for serum or urine pregnancy test 10. Patient provides voluntary written informed consent
Exclusion criteria
1. Previously received bevacizumab. 2. History of other invasive malignancy with the exception of nonmelanoma skin cancer 3. Participate in other drug trials 4. Blood pressure of \>150/100 mmHg on antihypertensive medications 5. Previous history of hypertensive crisis or hypertensive encephalopathy 6. Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure 7. The history of myocardial infarction within 6 months 8. The history of stroke or transient ischemic attack within 6 months of enrollment 9. Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease 10. Bleeding diathesis or coagulopathy 11. Presence of central nervous system or brain metastases 12. Pre-existing peripheral neuropathy of Grade ≥ 2 13. Major surgery was performed within 28 days prior to enrollment 14. Partial or complete ileus within 3 months prior to study enrollment 15. A biopsy or other minor surgery within 7 days prior to study enrollment 16. Positive pregnancy test or is lactating 17. Abdominal fistula, gastrointestinal perforation or abscess accumulation in the abdominal cavity within 6 months prior to study enrollment 18. Severe, nonhealing wound, ulcer, or bone fracture 19. Serious intercurrent medical or psychiatric illness, including serious active infection 20. Uncontrolled systemic infections require antiinfective treatment 21. Proteinuria at screening as demonstrated by either 22. Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR 23. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible) 24. Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | Assessed at the end of 6 cycle(each cycle is 21 days) | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-month progression-free survival rate | assessed up to 6 months | the percentage of participants with no progression event at 6 months after starting study treatment |
| progression-free survival | up to 3 years | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first |
| overall survival | assessed up to 3 years | Overall survival is defined as the time from treatment start until death from any cause |
| Disease control rate | Assessed at the end of 6 cycle(each cycle is 21 days) | the percentage of complete and partial response as well as stable disease |
Countries
China
Contacts
Primary ContactBeihua Kong
Outcome results
None listed