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

NCT ID: NCT01524575

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCC1 high expression

Patients with ERCC1 high expression tumors will be treated at discretion of investigator

Group Type: NO_INTERVENTION

No interventions assigned to this group

ERCC1 low expression

Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin

Group Type: EXPERIMENTAL

gemcitabine and oxaliplatin

Intervention Type: 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.

Interventions

gemcitabine and oxaliplatin

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.

Intervention Type: DRUG

Other Intervention Names

gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jared D Acoba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii Cancer Research Center

Locations

University of Hawaii

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

CRCH0904

Identifier Type: -

Identifier Source: org_study_id