Pancreas CancerPhase 2NCT06110598
CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)
A Phase 2 study testing Capecitabine in people with Pancreas Cancer and Pancreas Adenocarcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Adenocarcinoma
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
- 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
Read the 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.
- Conditions
- Pancreas Cancer, Pancreas Adenocarcinoma
- Being tested
- Capecitabine
- Keywords
- pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda®
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Extended adjuvant therapy with capecitabine | Experimental | * 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. Receives: Drug: Capecitabine |
| Arm B: Active surveillance | No intervention | * 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 being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
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.
Measured: 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 outcomes (1)
Overall survival (OS)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 2:1 to the treatment arm. There will be no blinding of participants and the trial will not be placebo-controlled
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee M Ocuin, MD, FACS, Principal investigator, Case Comprehensive Cancer Center, University Hospitals, Cleveland Medical Center, Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110598
- Sponsor's protocol ID
- CASE3223
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underline results reported in this publication after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)
- ClinicalTrials.gov ID
- NCT06110598
- Acronym / sponsor ID
- CASE3223
- Conditions
- Pancreas Cancer, Pancreas Adenocarcinoma
- Keywords
- pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to the treatment arm. There will be no blinding of participants and the trial will not be placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Arm A: Extended adjuvant therapy with capecitabine | Experimental | Drug: 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. |
| Arm B: Active surveillance | No intervention | –* 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: Xeloda®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. | Drug | Arm A: Extended adjuvant therapy with capecitabine |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. IPD that underline results reported in this publication after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee M Ocuin, MD, FACS principal investigator
Case Comprehensive Cancer Center, University Hospitals, Cleveland Medical Center, Seidman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Pancreas Cancer and Pancreas Adenocarcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.