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

NCT01524575 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CRCH0904
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Cancer; ERCC1

Keywords

pancreatic cancer; ERCC1; oxaliplatin; gemcitabine

Outcome Measures

Primary Outcomes (1)

• 6 month overall survival

  6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

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

Drug: gemcitabine and oxaliplatin

Interventions

gemcitabine and oxaliplatin DRUG

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.

Also known as: gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week

ERCC1 low expression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Jared D Acoba, MD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: February 2, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)