Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy

Primary Objectives:

To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone.

Secondary Objectives:

To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS).

To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates.

To assess the quality of life in patients receiving the study treatment.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine and Capecitabine

Detailed Description

The purpose of the research is to compare the usual treatment approach (chemotherapy followed by surgery) to using chemotherapy followed by surgery and then more chemotherapy. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the lifespan of patients compared to the usual approach. There will be two arms of the study. Arm one will receive treatment with gemcitabine and capecitabine every 28 days for 6 cycles. Arm two be will receive standard of care observation. Participants will be asked to undergo imaging (e.g., CT) and laboratory testing to monitor for disease recurrence. The time in the study will be for 30 months.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Howard S Hochster, MD; Phone Number: 732-235-2465; Email: howard.hochster@rutgers.edu
• Study Contact Backup: Name: Prateek Gulhati, MD, PhD; Phone Number: 732-235-2465; Email: pat.gulhati@rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Prateek Gulhati, MD; Phone Number: 732-253-5618; Email: pat.gulhati@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
• Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection
• Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2
• At least 18 years of age

• Adequate bone marrow and organ functions as defined by:

  • Absolute neutrophil count ≥ 1000 cells/ μL
  • Hemoglobin ≥ 8 g/ dL
  • Platelets > 75,000 / μL
  • Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
  • Total bilirubin ≤1.5 ULN
  • AST/ ALT < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN of normal
• Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately
• Ability to understand the nature of this study protocol and give written informed consent.
• Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures

Exclusion Criteria:

• Receipt of any investigational agents at the time of registration
• Known, untreated brain metastases
• Presence of metastatic disease or malignant ascites on diagnostic imaging
• Grade two or greater peripheral neuropathy
• Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments
• Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia
• Major surgery within the 4 weeks prior to initiation of study treatment
• A history of allergy or hypersensitivity to any of the study drugs
• Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study
• Pregnancy
• Severe hepatic impairment
• Participants with known malabsorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1- Gemcitabine and Capecitabine Treatment; Day 1, Day 8, Day 15 • Gemcitabine infused through a vein over 120 minutes Day 1 - Day 21 • Capecitabine tablets will be taken two times a day; once in the morning and once in the evening. The tablets should not be crushed or split and should be taken with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal.	Drug: Gemcitabine and Capecitabine; A chemotherapy cycle will constitute 28 days of treatment: Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle; Capecitabine: 1660 mg/m2 per day orally on days 1 through 21 of each 28-day cycle.
No Intervention: Group 2 - Observational; Usual therapy used to treat this type of cancer, chemotherapy plus radiation therapy. If cancer returns during observation, there will be offered standard of care therapy. Follow-up visits will be every three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by number of participants experiencing adverse events	Number of participants experiencing adverse events as defined by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity	Five Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the tumor with the Response Evaluation Criteria in Solid Tumors (RECIST)	Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1), when possible eleven Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements. Imaging for response assessment will be obtained before the initiation of conditioning and at the six-week follow up time point.	Five Years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Prateek Gulhati, MD, PhD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Gemcitabine Chemotherapy; Capecitabine Chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Gemcitabine
• Other Study ID Numbers: CINJ 072206; Pro2022000669 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No