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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Cancer, ERCC1

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 month overall survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jared D Acoba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Hawaii Cancer Research Center

Authority:

United States: Institutional Review Board

Study ID:

CRCH0904

NCT ID:

NCT01524575

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Metastatic Pancreatic Cancer
  • ERCC1
  • pancreatic cancer
  • ERCC1
  • oxaliplatin
  • gemcitabine
  • Pancreatic Neoplasms

Name

Location

University of HawaiiHonolulu, Hawaii  96813