Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1

Phase 2

Withdrawn

• Conditions: Metastatic Pancreatic Cancer; ERCC1
• Interventions: Drug: gemcitabine and oxaliplatin

• Registration Number: NCT01524575
• Lead Sponsor: University of Hawaii

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERCC1 low expression	gemcitabine and oxaliplatin	Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin

Primary Outcome Measures

Name	Time	Method
6 month overall survival	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States