Entry Detail
| General information | |
| Database: | DB00461 |
| Objective: | he combination of sunitinb (37.5 mg orally daily) + paclitaxel (90 mg/m intravenously on days 1, 8, 15 every 4 weeks) was examined in patients with advanced esophageal or gastroesophageal junction cancer, and progression free survival (PFS) was compared to that of historical controls. |
| Authors: | Schmitt JM, et al |
| Title: | Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group. |
| Journal: | J Thorac Oncol. |
| Year: | 2012 |
| PMID: | 22425927 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sunitinib plus paclitaxel |
| Study Type: | a phase II Study |
| Key Patients Feature: | Patients enrolled on study included adults with histologically proven recurrent or metastatic esophageal or GEjunction squamous cell or adenocarcinoma, who had receivedless than two chemotherapy regimens for locally advanced ormetastatic disease, and had measurable and/or evaluable disease as per the Response Evaluation Criteria in Solid Tumors(RECIST) criteria. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The combination of sunitinb (37.5 mg orally daily) + paclitaxel (90 mg/m intravenously on days 1, 8, 15 every 4 weeks) was examined |
| Primary End Point: | response rate, overall survival, and toxicities. |
| Secondary End Point: | NA |
| Patients Number: | 28 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Three (11%) of 23 evaluable patients had a response (1 complete response and 2 partial response) (90% CI, 3-25%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The 24week PFS rate was 25% (90% confidence interval [CI], 12-42%). |
| Median OS A vs. C: | 228 days (90% CI, 140-283 days) |
| Adverse Event(agent arm): | Grade 3/4 toxicities included leukopenia/ neutropenia (25%), anemia (18%), fatigue (11%), and hemorrhage (11%). There were four grade 5 toxicities including upper gastrointestinal hemorrhage (n = 2), gastrointestinal/esophageal fistula (n = 1), and unexplained death (n = 1) |
| Conclusions: | In their study, they found that sunitinib + paclitaxel in patients with advanced esophageal or gastroesophageal junction cancer had a 24week PFS no better than the PFS of historical controls. The combination also had a high rate of serious toxicities and will not be pursued. |