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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine and Capecitabine

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Gemcitabine Chemotherapy, Capecitabine Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rutgers Cancer Institute of New JerseyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1- Gemcitabine and Capecitabine Treatment

Group 2 - Observational

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05415917

First Posted

May 9, 2022

Last Updated

August 18, 2023

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT05415917

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2022 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Gemcitabine Chemotherapy, Capecitabine Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1- Gemcitabine and Capecitabine Treatment

Arm Type

Experimental

Arm Description

Arm Title

Group 2 - Observational

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and Capecitabine

Intervention Description

Primary Outcome Measure Information:

Title

Safety as assessed by number of participants experiencing adverse events

Description

Number of participants experiencing adverse events as defined by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity

Time Frame

Five Years

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

Five Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Prateek Gulhati, MD, PhD

Phone

732-235-2465

pat.gulhati@rutgers.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Howard S Hochster, MD

Phone

732-235-2465

howard.hochster@rutgers.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prateek Gulhati, MD, PhD

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prateek Gulhati, MD

Phone

732-253-5618

pat.gulhati@rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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