Clinical trialPhase 2Completed
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- February 2005
- Expected end
- September 2012
- Enrollment
- 37 participants
- Sites
- 0
- Primary outcomes
- Objective Response of Tumor by RECIST 1.0 Criteria
- Sponsor
- Other
- Results posted
- 2013-04-18
- Last update
- 16 July 2014
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Brief summary public domain (ClinicalTrials.gov)
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
The study treatment for this protocol is * Loading dose of Cetuximab 400 mg/m2 * Weekly Cetuximab 250 mg/m2 * Bi-weekly Gemcitabine 50 mg/m2 * Daily Radiation for 28 fractions * CT scan four weeks after completion of treatment * Evaluation by surgeon for resectability
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response of Tumor by RECIST 1.0 Criteria [one month post-therapy]. Number, participants. partial response: Cetuximab, Gemcitabine, Radiotherapy (n=33): 10. stable disease: Cetuximab, Gemcitabine, Radiotherapy (n=33): 20. progressive disease: Cetuximab, Gemcitabine, Radiotherapy (n=33): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Assessed for Adverse Events [Participants were followed during treatment and for 30 days after completion of treatment]. Number, participants. Cetuximab, Gemcitabine, Radiotherapy (n=37): 37.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy [1 month after completion of treatment]. Number, participants. Cetuximab, Gemcitabine, Radiotherapy (n=33): 26.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. [One month post-therapy]. Number, percent. Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors (n=9): 33; Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors (n=24): 29.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease-Free Survival After Therapy [Five years post treatment]. Median, months (Full Range). Cetuximab, Gemcitabine, Radiotherapy (n=28): 9.1 (2 to NA) [Partipants did not all reach endpoint.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Length of Survival After Therapy [Five years post treatment]. Median, months (Full Range). Cetuximab, Gemcitabine, Radiotherapy (n=37): 17.3 (2 to NA) [Not all participants evaluated reached end point.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Pattern of Failure After Therapy [Five years post treatment]. Number, participants. number of participants with local recurrence only: Cetuximab, Gemcitabine, Radiotherapy (n=25): 2. number of ppts. with local and distant recurrence: Cetuximab, Gemcitabine, Radiotherapy (n=25): 1. number of ppts. with distant disease recurrence: Cetuximab, Gemcitabine, Radiotherapy (n=25): 17. number of ppts. without recurrence or unknown: Cetuximab, Gemcitabine, Radiotherapy (n=25): 5.