| General information |
| Database: | DB00675 |
| Objective: | Pancreatic cancer is the fourth commonest cause of death from cancer in men and women. Advantages in surgical techniques, radiation therapy techniques, chemotherapeutic regimes, and different combinedmodality approaches have yielded only a modest impact on the prognosis of patients with pancreatic cancer. Thus there is clearly a need for additional strategies. One approach involves using the identification of a number of molecular targets that may be responsible for the resistance of cancer cells to radiation or to other cytotoxic agents. As such, these molecular determinants may serve as targets for augmentation of the radiotherapy or chemotherapy response. Of these, the epidermal growth factor receptor (EGFR) has been a molecular target of considerable interest and investigation, and there has been a tremendous surge of interest in pursuing targeted therapy of cancers via inhibition of the EGFR. |
| Authors: | Krempien R, et al |
| Title: | Randomizedphase IIstudy evaluating EGFR targeting therapy with cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancerPARC: study protocol [ISRCTN56652283]. |
| Journal: | BMC Cancer. |
| Year: | 2005 |
| PMID: | 16219105 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine + cetuximab |
| Study Type: | an open, controlled, prospective, randomizedphase II trial |
| Key Patients Feature: | Age equal or greater than 18 years Primary inoperable locally advanced pancreatic adenocarcinoma No evidence of metastatic disease. Hb >10.0 g/%, WBC >3, 000 cells/mm3, platelets >100, 000 cells/mm3. Performance status: Karnofsky more than and equal to 70. No acute infections at the time of therapy initiation. Patient must be able to give informed consent Patient has given informed consent |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemoradiation + gemcitabine VS chemoradiation + gemcitabine and cetuximab |
| Treatment Info: | Patients in study arm A will be treated with chemoradiation using intensity modulated radiation therapy (IMRT) combined with gemcitabine and simultaneous cetuximab infusions. After chemoradiation the patients receive gemcitabine infusions weekly over 4 weeks. Patients in study arm B will be treated with chemoradiation using intensity modulated radiation therapy (IMRT) combined with gemcitabine and simultaneous cetuximab infusions. After chemoradiation the patients receive gemcitabine weekly over 4 weeks and cetuximab infusions over 12 weeks. A total of 66 patients with locally advanced adenocarcinoma of the pancreas will be enrolled. An interim analysis for patient safety reasons will be done one year after start of recruitment. |
| Primary End Point: | feasibility and the toxicity profile |
| Secondary End Point: | the role and the mechanism of cetuximab in patient's chemoradiation regimen, the response rate, the potential of this combined modality treatment, the time to progression interval and the quality of life |
| Patients Number: | 66 |
| 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): | NA |
| Conclusions: | NA |