Description:
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.
Title
- Brief Title: Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
CRCH0904
- NCT ID:
NCT01524575
Conditions
- Metastatic Pancreatic Cancer
- ERCC1
Interventions
| Drug | Synonyms | Arms |
|---|
| gemcitabine and oxaliplatin | gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week | ERCC1 low expression |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| ERCC1 high expression | No Intervention | Patients with ERCC1 high expression tumors will be treated at discretion of investigator | |
| ERCC1 low expression | Experimental | Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin | - gemcitabine and oxaliplatin
|
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 6 month overall survival |
| Time Frame: | 6 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | Assessments every 2 months until 2 years or death |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival |
| Time Frame: | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Best confirmed response |
| Time Frame: | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of overall response |
| Time Frame: | Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Withdrawn |
| Lead Sponsor: | University of Hawaii |
Trial Keywords
- pancreatic cancer
- ERCC1
- oxaliplatin
- gemcitabine
Last Updated
September 25, 2019
