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This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly paclitaxel + bevacizumab |
| ||
| Topotecan + bevacizumab |
| ||
| Pegylated liposomal doxorubicin + bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly paclitaxel | Drug | Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria | 36 months |
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with desease progression within 6 months of platinum treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30409490 | Derived | Lee JY, Park JY, Park SY, Lee JW, Kim JW, Kim YB, Jeong DH, Lee KB, Kim TH, Lee IH, Choi MC, Kim KH, Kim YM, Lee YJ, Kang S; KGOG Investigators; Pujade-Lauraine E. Real-world effectiveness of bevacizumab based on AURELIA in platinum-resistant recurrent ovarian cancer (REBECA): A Korean Gynecologic Oncology Group study (KGOG 3041). Gynecol Oncol. 2019 Jan;152(1):61-67. doi: 10.1016/j.ygyno.2018.10.031. Epub 2018 Nov 6. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| C506643 | liposomal doxorubicin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
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| Topotecan | Drug | Drug: topotecan 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle |
|
| Pegylated liposomal doxorubicin | Drug | Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks |
|
| Bevacizumab | Drug | Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks |
|
| 36 months |
| overall survival (OS) | Duration of overall survival was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. | 36 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000911 |
| Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |