| General information |
| Database: | DB00537 |
| Objective: | Thisphase II trial assessed the activity and tolerability of cetuximab (C225, Erbitux) in combination with carboplatin in patients with relapsed platinumsensitive ovarian or primary peritoneal carcinoma. |
| Authors: | Secord AA, et al |
| Title: | Phase II trial of cetuximab and carboplatin in relapsed platinumsensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. |
| Journal: | Gynecol Oncol. |
| Year: | 2008 |
| PMID: | 18191993 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | ovarian cancer |
| Cancer Subtype: | ovarian cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab and carboplatin |
| Study Type: | Phase II Trial |
| Key Patients Feature: | Eligible patients must have had platinumsensitive recurrent epithelial ovarian or primaryperitoneal carcinoma to enroll on Gynecologic Oncology Group (GOG) protocol 146P.Confirmation of persistent or recurrent disease was required and could be documented eitherclinically or histologically. Patients must have had one prior platinumbased chemotherapeuticregimen for management of primary disease. This initial treatment may have includedconsolidation therapy, or extended therapy administered after surgical or nonsurgicalassessment. Patients who had not received initial therapy with paclitaxel may have received asecond regimen that included paclitaxel. |
| Biomarker: | Immunohistochemical expression of EGFR was evaluated in tumor specimens from patients enrolled in this trial. |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were to receive combination therapy with cetuximab (initial dose of 400 mg/m2 intravenously on cycle 1, day 1, followed by weekly infusions of 250 mg/m2) and carboplatin (AUC of 6 on day 1 and every 3 weeks). |
| Primary End Point: | antitumor activity and adverse events |
| Secondary End Point: | NA |
| Patients Number: | 29 |
| Trial Results |
| DLT_MTD: | The most commonly observed adverse events were dermatologic toxicity (grade 3 in 32%), thrombocytopenia (grade 3 in 14%), and hypersensitivity reactions (grade 3 and 4 in 18%). |
| Objective Response Rate: | 26 hadEGFRpositive tumors and the response rate in this group of patients was as follows: 9 demonstratedan objective response (3 CR; 6 PR) and 8 had stable disease |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.4+ months (range: .9- 22.2+). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most commonly observed adverse events were dermatologic toxicity (grade 3 in 32%), thrombocytopenia (grade 3 in 14%), and hypersensitivity reactions (grade 3 and 4 in 18%). |
| Conclusions: | Cetuximab administered in combination with carboplatin had modest activity in screened patients with EGFRpositive, relapsed platinumsensitive ovarian or primary peritoneal carcinoma. Cetuximab was associated with an acneiform rash in a majority of patients and occasional serious hypersensitivity reactions. |