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Gemcitabine and CT-011 for Resected Pancreatic Cancer

NCT01313416 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-07-10

Study results available
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Summary

Background:

* In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer carries a poor prognosis with an overall 5-year relative survival rate of 5.6%.
* Many doctors believe that individuals who have had surgery to remove pancreatic cancer should receive additional treatment, known as adjuvant therapy or adjuvant treatment, to prevent the cancer from returning. One chemotherapy drug that has been found to be effective in some patients with pancreatic cancer is called gemcitabine; it has been shown to improve patient survival by 6 months. Researchers are searching for new drugs or drug combinations to improve on these results.
* One of the leading causes for immune suppression in cancer patients was suggested to be associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by surrounding cells like regulatory immune cells, resulting in the local suppression and apoptosis of tumor infiltrating effector lymphocytes.
* Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune system from helping in that fight. The experimental drug CT-011 is designed to help the immune system remain active to fight cancer cells. CT-011 has been tested in laboratories and studied for use with a number of other cancers, but it has not been given in combination with gemcitabine as a treatment for pancreatic cancer.

Objective:

\- To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a follow-up treatment for pancreatic cancer that has been surgically removed.

Eligibility:

\- Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and have not had other types of follow-up treatments.

Design:

* Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and will be monitored throughout their treatment.
* Participants who do not have serious side effects and remain cancer-free may receive this drug combination every 28 days for a total of 6 cycles.
* Participants will have follow-up visits with additional blood tests every 2 months after stopping treatment for up to 2 years.

Conditions

  • Pancreatic Neoplasms
  • Cancer of the Pancreas
  • Neoplasms Pancreatic
  • Pancreatic Cancer
  • Pancreas Cancer

Interventions

BIOLOGICAL

CT-011

3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

DRUG

Gemcitabine

1000mg/m\^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Samir N. Khleif, MD · Augusta University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313416 on ClinicalTrials.gov