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

NCT02767752 | Terminated Phase 2 DMC

• 1 other identifier: GI 1604
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Resectable pancreatic cancer; Adjuvant

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Time from the date of randomization to the date of disease recurrence or death, whichever is earlier.

  up to approximately 9 months

Secondary Outcomes (3)

• Overall Survival

  up to approximately 18 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to approximately 18 months

• Quality of Life

  up to approximately 18 months

Other Outcomes (2)

• Determination of plasma YKL-40

  up to approximately 9 months

• Determination of plasma IL-6

  up to approximately 9 months

Study Arms (2)

T-ChOS + Gemcitabine + Capecitabine

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Capecitabine

Placebo + Gemcitabine + Capecitabine

PLACEBO COMPARATOR

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; Drug: Capecitabine

Interventions

T-ChOS DIETARY_SUPPLEMENT

Also known as: Benecta™

T-ChOS + Gemcitabine + Capecitabine

Gemcitabine DRUG

Placebo + Gemcitabine + Capecitabine; T-ChOS + Gemcitabine + Capecitabine

Placebo DIETARY_SUPPLEMENT

Also known as: Sugar pill manufactured to mimic 300 mg capsule

Placebo + Gemcitabine + Capecitabine

Capecitabine DRUG

Also known as: Xeloda

Placebo + Gemcitabine + Capecitabine; T-ChOS + Gemcitabine + Capecitabine

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
• Subject should be able to start treatment no later than 12 weeks post-surgery
• Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
• ECOG/WHO Performance Status (PS) 0-1
• 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
• 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
• Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
• Be able to adhere to the study visit schedule and other protocol requirements
• Acceptable hematology parameters defined as:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
• Platelet count ≥ 100 x 10⁹/L

You may not qualify if:

• Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
• Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
• 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
• 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:
• 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
• Known or suspected allergy to the investigational agents or any agents given in association with this trial
• Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
• Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Any condition that confounds the ability to interpret data from the study
• Unwillingness or inability to comply with study procedures
• Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted

Sponsors & Collaborators

• Herlev Hospital: lead
• GENIS: collaborator

Study Sites (1)

Department of Oncology

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Sugars; Capecitabine

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; Carbohydrates; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Inna Chen, MD

  Herlev & Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff specialist

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)