Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | December 2011 |
| End Date: | March 2019 |
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)
The current trial will provide important data on the recurrence rates and patterns of failure
using state of the art target agent, chemotherapy and proton beam technology for patients
with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater
would be considered evidence of a regimen potentially worthy of further study as a new
treatment paradigm in one arm in a future phase III trial.
using state of the art target agent, chemotherapy and proton beam technology for patients
with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater
would be considered evidence of a regimen potentially worthy of further study as a new
treatment paradigm in one arm in a future phase III trial.
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma
of the pancreas
- AJCC stage I-III with unresectable or borderline unresectable disease as defined by
NCCN guidelines
- Radiological resectability is defined by the following criteria on abdominal imaging:
1. No evidence of tumor extension to the celiac axis, hepatic artery or superior
mesenteric artery.
2. No evidence of tumor encasement or occlusion of the superior mesenteric vein
(SMV) or the SMV/portal vein confluence
3. No evidence of visceral or peritoneal metastases
- Borderline and Unresectable cases would be defined as those that do not meet the
criteria in section and also show no evidence of distant metastatic or intraperitoneal
disease.
- Eastern Cooperative Oncology Group performance status of ≤ 2
- Age > 18 years
- Adequate hematologic reserve, hepatic reserve and renal function
- WBC > 2,000 cells/mm3
- ANC > 1,500 cells/mm3
- Platelets > 100,000 cells/mm3
- Serum bilirubin ≤ 2.5 mg/dL
- Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥
30ml/min
- ALT < 3 times ULN
- AST < 3 times ULN
- Albumin > 3.2 g/dl
- Patient must sign study-specific informed consent
We found this trial at
1
site
11234 Anderson St
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Gary Yang, MD
Phone: 909-558-4280
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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