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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- 6 month overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ERCC1 low expression
Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin
Intervention: gemcitabine and oxaliplatin (Drug)
Outcomes
Primary Outcomes
6 month overall survival
Time Frame: 6 months
Secondary Outcomes
- Progression free survival(Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years)
- Overall survival(Assessments every 2 months until 2 years or death)
- 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)