Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00871169
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan, oxaliplatin, and cetuximab — DRUG
    Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.

Study Details

This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Key Dates

Start date
Oct 31, 2008
Status verified
May 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan, oxaliplatin, and cetuximab
    The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cancer Center at Presbyterian HospitalAlbuquerqueNew Mexico87110-
Hematology Oncology AssociatesAlbuquerqueNew Mexico87106-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87131-0001-
University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerqueNew Mexico87102-
Memorial Medical Center- Cancer CenterLas CrucesNew Mexico88011-

Find similar trials in Albuquerque, NM

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Cancer Center at Presbyterian Hospital· Albuquerque, NMHematology Oncology Associates· Albuquerque, NMUniversity of New Mexico Cancer Center· Albuquerque, NMUniversity of New Mexico Cancer Center @ Lovelace Medical Center· Albuquerque, NMMemorial Medical Center- Cancer Center· Las Cruces, NM

Related Studies