A Phase 2 interventional study of Capecitabine in Pancreas Cancer and Pancreas Adenocarcinoma, sponsored by Case Comprehensive Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care
- 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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
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Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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Participants must have normal organ and marrow function as defined below:
Exclusion Criteria:
* 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
* 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.
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.
Also known as: Xeloda®
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.
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)
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.
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
Plan to share: Yes — IPD that underline results reported in this publication after deidentification
Supporting information: Study protocol
Time frame: Starting 9 months and ending 36 months following article publication
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.
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This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Capecitabine
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