Clinical trial NCT01524575: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
ERCC1
Keywords: pancreatic cancer
ERCC1
oxaliplatin
gemcitabine
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6 month overall survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: Assessments every 2 months until 2 years or death
measure: Progression free survival
timeFrame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
measure: Best confirmed response
timeFrame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
measure: Duration of overall response
timeFrame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Jared D Acoba, MD
role: PRINCIPAL_INVESTIGATOR
References: