Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2012 |
| End Date: | January 2014 |
| Contact: | Jared D Acoba, MD |
| Email: | jacoba@hawaii.edu |
| Phone: | 8085318521 |
Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1)
The goal of this clinical trial is to improve and personalize pancreatic cancer care to
deliver the most effective therapy while avoiding unnecessary exposure to potential side
effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression
predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are
much more likely to respond to cisplatin than those whose tumors produce large amounts. The
hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective
regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of
ERCC1.
deliver the most effective therapy while avoiding unnecessary exposure to potential side
effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression
predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are
much more likely to respond to cisplatin than those whose tumors produce large amounts. The
hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective
regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of
ERCC1.
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- Patients must not have had prior chemotherapy or biologic therapy for metastatic
pancreatic cancer
- Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for
locally advanced disease is allowed but must have been administered > 6 months prior
to registration
- ECOG Performance Status of 0, 1, or 2
- Adequate hematologic, hepatic and renal function
Exclusion Criteria:
- Pregnant or nursing women
- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer
from which the patient has been disease-free for 5 years
- Patients must not have known brain metastases
- Any other condition that in the opinion of the Investigator may render the patient at
excessive risk for treatment complications
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