Gemcitabine and CT-011 for Resected Pancreatic Cancer

NCT01313416 | Terminated Phase 2 Results DMC

• 1 other identifier: 11-C-0100
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adjuvant Therapy; Recombinant Monoclonal Antibody; Adenocarcinoma of the Pancreas; Vaccination; PD-1 Receptor; Pancreas Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity Evaluation: From Time of First Treatment With CT-011 (Pidilizumab, MDV9300)

  Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e: * Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels; * Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy. * Visual symptoms should be immediately evaluated by an ophthalmologist. * Generalized rash should be biopsied prior to local skin care, antihistamines or corticosteroids. * Pulmonary symptoms will be evaluated immediately, including repeated PFTs (pulmonary function tests).

  2 years

Secondary Outcomes (1)

• Disease Response: Evaluated Using the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (v1.1)

  2 years

Study Arms (1)

Single arm

EXPERIMENTAL

Combination CT-011 and Gemcitabine

Biological: CT-011; Drug: Gemcitabine

Interventions

CT-011 BIOLOGICAL

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

Also known as: Anti-PD1 Antibody

Single arm

Gemcitabine DRUG

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

Also known as: Gemzar

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Adult patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1) who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1 resections are excluded. * Must meet all laboratory safety criteria and not have active or history of autoimmune disease or conditions, be treated with immunosuppressive drugs, or require the use of systemic steroids. Primary intraoperative chemotherapy will be allowed. * Pregnant or nursing women will be excluded. Subjects with active infection, HIV, Hepatitis B or C will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Related Publications (4)

• Geer RJ, Brennan MF. Prognostic indicators for survival after resection of pancreatic adenocarcinoma. Am J Surg. 1993 Jan;165(1):68-72; discussion 72-3. doi: 10.1016/s0002-9610(05)80406-4.

  PMID: 8380315 BACKGROUND

• Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7.

  PMID: 10401733 BACKGROUND

• Saif MW. Adjuvant treatment of pancreatic cancer in 2009: where are we? Highlights from the 45th ASCO annual meeting. Orlando, FL, USA. May 29-June 2, 2009. JOP. 2009 Jul 6;10(4):373-7.

  PMID: 19581737 BACKGROUND

• Miller RC, Iott MJ, Corsini MM. Review of adjuvant radiochemotherapy for resected pancreatic cancer and results from Mayo Clinic for the 5th JUCTS symposium. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):364-8. doi: 10.1016/j.ijrobp.2008.11.069.

  PMID: 19735864 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pidilizumab; spartalizumab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Samir Khleif
• Organization: Georgetown University

snk48@georgetown.edu

(202) 687-0100

Study Officials

• Samir N. Khleif, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cancer Center Director

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: September 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)