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

NCT05415917 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: CINJ 072206Pro2022000669
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Gemcitabine Chemotherapy; Capecitabine Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To measure the tumor with the Response Evaluation Criteria in Solid Tumors (RECIST)

  Five Years

Study Arms (2)

Group 1- Gemcitabine and Capecitabine Treatment

EXPERIMENTAL

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

Group 2 - Observational

NO INTERVENTION

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.

Interventions

Gemcitabine and Capecitabine DRUG

A chemotherapy cycle will constitute 28 days of treatment: 1. Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle 2. Capecitabine: 1660 mg/m2 per day orally on days 1 through 21 of each 28-day cycle.

Group 1- Gemcitabine and Capecitabine Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

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

Study Officials

• Prateek Gulhati, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prateek Gulhati PI Assistant Professor, Department of Gastrointestinal Medical Oncology

Model Details: A chemotherapy cycle will constitute 28 days of treatment: 1. Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle 2. Capecitabine: 1660 mg/m2 per day orally on days 1 through 21 of each 28-day cycle.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 13, 2022
• Study Start: July 29, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: May 7, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)