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

Metastatic Pancreatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01524575
• Other study ID #: CRCH0904
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2019
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ERCC1
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month overall survival		6 months
Secondary	Overall survival		Assessments every 2 months until 2 years or death
Secondary	Progression free survival		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Secondary	Best confirmed response		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Secondary	Duration of overall response		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years