ERCC1, Metastatic Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, ERCC1, oxaliplatin, gemcitabine
Brief summary
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.
Interventions
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.
Sponsors
University of Hawaii
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month overall survival | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Assessments every 2 months until 2 years or death |
| Progression free survival | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
| Best confirmed response | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
| Duration of overall response | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
Countries
United States
Outcome results
None listed