CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)

August 14, 2024 updated by: Case Comprehensive Cancer Center
  • This study is being done to find out if extending adjuvant chemotherapy for patients by giving additional chemotherapy can lengthen the amount of time before their cancer comes back. The additional chemotherapy is called capecitabine.
  • Capecitabine is an oral drug (taken by mouth). It is approved by the US Food and Drug Administration (FDA) for adjuvant treatment of adults with pancreatic cancer and also for the treatment of other types of cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

- Pancreatic adenocarcinoma remains one of the deadliest common solid tumor malignancies with an overall survival of 11% at 5 years for all comers. Approximately 50% of patients present with metastatic disease at the time of diagnosis. Approximately 20% of patients have localized disease at diagnosis and are candidates for surgical resection, which is necessary but not sufficient for long-term survival, and the most optimal survival outcomes are seen with multimodal therapy. The recently published SWOG S1505 study demonstrated that participants with localized pancreatic adenocarcinoma treated with either of the two most active multi-agent regimens (FOLFIRINOX or gemcitabine with nab-paclitaxel) in the perioperative setting had a median recurrence-free survival of 10.9-14.2 months, and 2-year overall survival of 47-48% (median: 23.2 vs. 23.6 months), which is similar to outcomes observed in older studies examining the efficacy of gemcitabine monotherapy or 5-FU monotherapy.

Currently, there are no guideline recommendations for extension of adjuvant therapy upon completion of all standard therapy (defined as surgery, multi-agent chemotherapy, + radiotherapy) for localized pancreatic adenocarcinoma. EA2192 (APOLLO; https:// clinicaltrials. gov/ct2/show/NCT04858334), a phase II randomized controlled trial, is currently accruing and investigating the efficacy of twelve months of olaparib on relapse-free survival in participants with germline BRCA- or PALB2-mutated pancreatic adenocarcinoma, which accounts for a small minority (4-7%) of cases. Olaparib was found to improve progression-free survival in participants with germline-mutated BRCA or PALB2 metastatic pancreatic adenocarcinoma. There are no trials examining extension of adjuvant therapy after completion of all standard therapy in the non-genomically selected patients with localized disease, who comprise 93-96% of these pancreas cancer patients.

- This study will be a phase 2 randomized clinical trial, with a 2:1 merged blocked, stratified randomization to the treatment arm to test the efficacy of extended adjuvant therapy in delaying disease relapse following completion of all standard therapy for localized pancreatic adenocarcinoma, as compared to the standard of care, which is active surveillance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Participants must have undergone curative-intent surgical resection and received at least 4 months of multi-agent cytotoxic chemotherapy, regardless of treatment sequence or chemotherapy backbone.
  • Participants must be within 12 weeks of completion of standard perioperative therapy (defined as resection, multi-agent systemic chemotherapy, + radiotherapy, regardless of treatment sequence).
  • Participants must have absence of or unknown BRCA1, BRCA2, or PALB2 germline or somatic mutational status.
  • Participants must have no evidence of recurrent disease.
  • Age >18 years because no high-quality dosing or adverse event data are currently available on the use of capecitabine in in participants ≤18 years of age. Additionally, pancreatic adenocarcinoma is exceedingly rare in participants <18 years of age. Therefore, children are excluded from this study.
  • ECOG(Eastern Cooperative Oncology Group) Performance status < 2.

  • Participants must have normal organ and marrow function as defined below:

    • Hemoglobin ≥ 10.0 g/dl
    • Leukocytes ≥ 3,000/mcL
    • Absolute neutrophil count ≥ 1,500/mcL
    • Platelet count ≥ 100,000/mcL
    • Total bilirubin within normal institutional limits
    • AST(Aspartate aminotransferase) (SGOT) ≤ 2.5 X institutional upper limit of normal
    • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
    • Serum Creatinine within normal institutional limits
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior treatment toxicities resolved to ≤ Grade 3 according to NCI CTCAE Version 5.0 (list exceptions, e.g. alopecia, neuropathy, fatigue, etc).
  • Participants receiving any other investigational agents or participating in clinical trials that use OS or PFS(progression-free survival) as their primary or secondary endpoints would prohibit participation in the current study. Patients enrolled or previously enrolled in non-therapeutic trials, or trials with only correlative endpoints are allowed.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or 5-fluorouracil.
  • Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Participants with known low or absent dihydropyimidine dehydrogenase (DPD)activity
  • Women who are pregnant or breastfeeding are excluded from this study because capecitabine is a category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with capecitabine, breastfeeding should be discontinued if the mother is treated with capecitabine.
  • Participants who are known to be HIV-positive on combination antiviral therapy are ineligible because of the potential for pharmacokinetic interaction with capecitabine. In addition, these participants are at increased risk of lethal infections when treated with marrow suppressive therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Extended adjuvant therapy with capecitabine
  • Participants randomized to Arm A will take capecitabine (1000mg by mouth twice a day, 3-week cycle [2 weeks on therapy, 1 week off]) for up to 18 cycles, or until progression or intolerance to therapy develops.
  • Participants who remain without disease recurrence at completion of 18 cycles of therapy who wish to continue therapy may do so at the discretion of their treating medical oncologist. Participants will be followed at standard 12-week intervals, where they will undergo routine cross-sectional imaging and labs.
Drug: Capecitabine
Capecitabine is an oral prodrug that is enzymatically converted to 5-fluorouracil (5-FU) in vivo. Both normal and tumor cells metabolize 5-FU to 5-fluoro-2'-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10-methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2'-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division. Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.
Other Names:
  • Xeloda®
No Intervention: Arm B: Active surveillance
  • Participants randomized to Arm B will undergo active surveillance, with no active treatment for the duration of their participation in the study.
  • Participants in Arm B will undergo re-staging every 12 weeks (+/- 7 days), consisting of cross-sectional imaging (CT or PET-CT) and labs (CBC, chemistry panel, CA19-9 and blood draw for ctDNA). In addition to re-staging every 12 weeks, participants may be seen by their medical or surgical oncologist as clinically indicated. Participants who experience disease relapse may transition to palliative systemic therapy or best supportive care at the discretion of their treating medical oncologist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relapse-free survival (RFS)
Time Frame: Assessed every 3 months from the date of randomization until the first documentation of disease relapse or death, up to 24 months, and then every 6 months after the initial 24 months up to 4 years
Relapse-free survival (RFS), defined as the time from randomization to first documentation of disease relapse or death, defined as radiographic evidence of local or distant primary tumor relapse, whichever occurs first; participants alive without relapse will be censored at the date of last disease assessment.
Assessed every 3 months from the date of randomization until the first documentation of disease relapse or death, up to 24 months, and then every 6 months after the initial 24 months up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Assessed every 3 months from the date of randomization until the first documentation of disease relapse or death, up to 24 months, and then every 6 months after the initial 24 months up to 4 years
Overall survival (OS), defined as the time from randomization to death from any cause; participants still living will be censored at the date last known to be alive.
Assessed every 3 months from the date of randomization until the first documentation of disease relapse or death, up to 24 months, and then every 6 months after the initial 24 months up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lee M Ocuin, MD, FACS, Case Comprehensive Cancer Center, University Hospitals, Cleveland Medical Center, Seidman Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE3223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underline results reported in this publication after deidentification

IPD Sharing Time Frame

Starting 9 months and ending 36 months following article publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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