| General information |
| Database: | DB00300 |
| Objective: | Thisphase II, openlabel, randomised study evaluated whether patients with metastatic pancreatic cancer receiving erlotinib/gemcitabine derived survival benefits from increasing the erlotinib dose. |
| Authors: | Van Cutsem E, et al |
| Title: | Dose escalation to rash for erlotinib plus gemcitabine for metastatic pancreatic cancer: the phase II RACHEL study. |
| Journal: | Br J Cancer. |
| Year: | 2014 |
| PMID: | 25247318 |
| Trial Design |
| Clinical Trial Id: | NCT00652366 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | erlotinib+ gemcitabine |
| Study Type: | a multicentre, randomised, openlabel, phase II study |
| Key Patients Feature: | Patients ( 18 years) had: histologically/cytologically confirmed pancreatic cancer (adenocarcinoma) with measurable/nonmeasurable disease (stage IV); ECOG PS 0 to 1; life expectancy 8 weeks; and adequate haematological/renal/liver function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabine+erlotinib dose escalation (150 mg, increasing by 50 mg every 2 weeks (maximum 250 mg); n=71)(arm A) versus gemcitabine+standarddose erlotinib (100 mg per day; n=75)(arm B) |
| Treatment Info: | After a 4week runin period (gemcitabine 1000 mg m(2) once weekly plus erlotinib 100 mg per day), patients were randomised to receive gemcitabine plus erlotinib dose escalation (150 mg, increasing by 50 mg every 2 weeks (maximum 250 mg); n=71) or gemcitabine plus standarddose erlotinib (100 mg per day; n=75). |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | progression free survival (PFS), incidence of grade 2 rash, and safety. |
| Patients Number: | 467 |
| Trial Results |
| DLT_MTD: | Erlotinib dose escalation induced grade 2 rash in 29 out of 71 (41.4%) patients compared with 7 out of 75 (9.3%) patients on standard dose. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS: median 3.5 vs 4.5 months, respectively, HR, 1.09, 95% CI: 0.771.54; P=0.6298). |
| Median OS A vs. C: | median 7.0 vs 8.4 months, respectively, hazard ratio (HR), 1.26, 95% confidence interval (CI): 0.881.80; P=0.2026 |
| Adverse Event(agent arm): | Incidence of adverse events was comparable between randomised arms. |
| Conclusions: | The erlotinib doseescalation strategy induced rash in some patients; there was no evidence that the higher dose translated into increased benefit. |