Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (CHIPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767752
Recruitment Status : Terminated (Poor accrual and change of SOC (FOLFIRINOX in adjuvant setting))
First Posted : May 10, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
GENIS
Information provided by (Responsible Party):
Inna Chen, MD, Herlev Hospital

Brief Summary:
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Dietary Supplement: T-ChOS Drug: Gemcitabine Dietary Supplement: Placebo Drug: Capecitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer.
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: T-ChOS + Gemcitabine + Capecitabine

T-ChOS: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.

Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.

Dietary Supplement: T-ChOS
Other Name: Benecta™

Drug: Gemcitabine
Drug: Capecitabine
Other Name: Xeloda

Placebo Comparator: Placebo + Gemcitabine + Capecitabine

Placebo: 600 mg given p.o. (two capsules, each 300 mg) daily in the morning 30 minutes before food.

Gemcitabine: 1000 mg/m²i.v. on day 1, day 8 and day 15 of every 28 day cycle. Capecitabine: 1660 mg/m²/day p.o. twice daily 21/28 day i. e. 24 weeks.

Drug: Gemcitabine
Dietary Supplement: Placebo
Other Name: Sugar pill manufactured to mimic 300 mg capsule

Drug: Capecitabine
Other Name: Xeloda




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: up to approximately 9 months ]
    Time from the date of randomization to the date of disease recurrence or death, whichever is earlier.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to approximately 18 months ]
    Time from the date of randomization to the date of death

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to approximately 18 months ]
    Assesment by CTCAE v4.0

  3. Quality of Life [ Time Frame: up to approximately 18 months ]
    Quality of Life Questionnaire C30 (QLQ-C30) Version 3.0


Other Outcome Measures:
  1. Determination of plasma YKL-40 [ Time Frame: up to approximately 9 months ]
    Measurement using an enzyme linked-immunosorbent assay

  2. Determination of plasma IL-6 [ Time Frame: up to approximately 9 months ]
    Measurement using an enzyme linked-immunosorbent assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
  3. Subject should be able to start treatment no later than 12 weeks post-surgery
  4. Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
  5. ECOG/WHO Performance Status (PS) 0-1
  6. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:

    • Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3months following the last dose of IP
    • Has negative serum pregnancy test (β-hCG) result at screening
  7. Male subjects:

    • Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy

  8. Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
  9. Be able to adhere to the study visit schedule and other protocol requirements
  10. Acceptable hematology parameters defined as:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
    • Platelet count ≥ 100 x 10⁹/L
    • Haemoglobin ≥ 5.6 mmol/L
  11. Acceptable liver function defined as:

    • Serum bilirubin < 1.5 x upper limit of normal (ULN)
    • ASAT/ALAT < 2.5 x ULN
  12. Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the Cockroft-Gault formula)

Exclusion Criteria:

  1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
  2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
  3. Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
  4. History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:

    • Active infection requiring antibiotics within 2 weeks before the study inclusion
    • Concurrent congestive heart failure NYHA class III - IV
    • Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
    • History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
    • Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
  5. Known or suspected allergy to the investigational agents or any agents given in association with this trial
  6. Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
  7. Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
  8. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  9. Any condition that confounds the ability to interpret data from the study
  10. Unwillingness or inability to comply with study procedures
  11. Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767752


Locations
Layout table for location information
Denmark
Department of Oncology
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
GENIS
Investigators
Layout table for investigator information
Principal Investigator: Inna Chen, MD Herlev & Gentofte Hospital
Layout table for additonal information
Responsible Party: Inna Chen, MD, Staff specialist, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02767752    
Other Study ID Numbers: GI 1604
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Inna Chen, MD, Herlev Hospital:
Resectable pancreatic cancer
Adjuvant
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs