Entry Detail
| General information | |
| Database: | DB00543 |
| Objective: | New agents are required for the patients with epithelial ovarian cancer (EOC) who progress after first and second line of the treatment. Tumor vasculature targeted agents are potentially active in EOC. They aimed to assess the activity of sorafenib in patients with recurrent EOC who had received two prior therapies. |
| Authors: | Bodnar L, et al |
| Title: | Sorafenib as a third line therapy in patients with epithelial ovarian cancer or primary peritoneal cancer: a phase II study. |
| Journal: | Gynecol Oncol. |
| Year: | 2011 |
| PMID: | 21723597 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | ovarian carcinoma or primary peritoneal carcinoma |
| Cancer Subtype: | epithelial ovarian carcinoma or primary peritoneal carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II, nonrandomized, single arm, openlabel study |
| Key Patients Feature: | Women with histologically or cytologically confirmed EOC or PSCafter treatment with two prior cytotoxic regimens, who hadmeasurable disease that was considered unresectable were eligiblefor this study. Inclusion criteria included age of over 18 years, EasternCooperative Oncology Group performance status (ECOG PS) of 0-2, and adequate hematopoietic function (plateletsmore than and equal to 60, 000/L, hemoglobinmore than and equal to 9 g/dL, and absolute neutrophil count [ANC]more than and equal to 1500 cells/L), renal function (serum creatinineless than and equal to 2 times the upper limit of normal), and liver function (ASTless than and equal to 5 the times upper limit of normal, ALTless than and equal to 5the upper limit of normal, and bilirubinless than and equal to 2.5 times upper limit ofnormal). Patients were excluded from the study in case of a history ofbone marrow transplantation, a history of prior malignancy (with theexception of curatively treated carcinoma in situ of cervix, superficialbladder tumors (Ta, Tis, T1), basal cell or squamous cell skin cancer orany cancer curatively treated N3 years prior to study entry) andclinically significant cardiac disease, hypocalcemia or a systemicinfection.Prior surgery, chemotherapy and/or radiation were permitted ifthey had been completed at least 4 weeks before the enrolment. Priorhormonal therapy was permitted, however prior antiangiogenic/noncytotoxic treatment was not. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sorafenib was administered as 400 mg twice daily on days 128 of each 4week cycle. |
| Primary End Point: | PFS |
| Secondary End Point: | time to progression (TTP), duration of response, overall survival (OS), clinical benefit [(CB)=CR+PR+SD], safety and tolerability (adverse events, toxicity, vital signs, laboratoryabnormalities). |
| Patients Number: | 11 |
| Trial Results | |
| DLT_MTD: | There were no grade 4 toxicities and few grade 3 toxicities. |
| Objective Response Rate: | no patients experienced a partial response or complete response or stable diseaselasting longer than 6 months according to RECIST criteria |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.00 months (95% CI, 1, 80-3, 90) |
| Median OS A vs. C: | 11.78 months (95% CI, 7.66 to 15.39) |
| Adverse Event(agent arm): | There were no grade 4 toxicities and few grade 3 toxicities. |
| Conclusions: | Sorafenib fails to achieve sufficient objective response or sustained disease stabilization as thirdline treatment for EOC. |