| General information |
| Database: | DB00899 |
| Objective: | To determine the maximal tolerated dose of erlotinib when added to 5fluorouracil (5FU) chemoradiation and bevacizumab and safety and efficacy of this combination in patients with locally advanced rectal cancer. |
| Authors: | Blaszkowsky LS, et al |
| Title: | Phase I/II study of neoadjuvant bevacizumab, erlotinib and 5fluorouracil with concurrent external beam radiation therapy in locally advanced rectal cancer. |
| Journal: | Ann Oncol. |
| Year: | 2014 |
| PMID: | 24356623 |
| Trial Design |
| Clinical Trial Id: | NCT00307736 |
| Agent: | bevacizumab, erlotinib
|
| Target: | NA
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced rectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | bevacizumab, erlotinib + 5fluorouracil with concurrent external beam radiation therapy |
| Study Type: | Phase I/II study |
| Key Patients Feature: | Patients with Magnetic resonance imaging (MRI) or ultrasound defined T3 or T4 adenocarcinoma of the rectum and without evidence of metastatic disease were enrolled. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received infusional 5FU 225 mg/M2/day continuously, along with bevacizumab 5 mg/kg days 14, 1, 15 and 29. Standard radiotherapy was administered to 50.4 Gy in 28 fractions. Erlotinib started at a dose of 50 mg orally daily and advanced by 50 mg increments in the subsequent cohort. Open total mesorectal excision was carried out 69 weeks following the completion of chemoradiation |
| Primary End Point: | MTD DLT |
| Secondary End Point: | NA |
| Patients Number: | 32 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | At least one grade 34 toxicity occurred in 46.9% of patients. Grade 34 diarrhea occurred in 18.8%. |
| Conclusions: | Erlotinib added to infusional 5FU, bevacizumab and radiation in patients with locally advanced rectal cancer is relatively well tolerated and associated with an encouraging pCR |