Clinical trial · Interventional
Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene
Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2-Line Treatment of Advanced Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Survival at 6-months
- measure
- Toxicity
Secondary outcomes (3)
- measure
- Association between capecitabine exposure at steady-state, allelic variants in candidate genes, and drug response
- measure
- Relationship between expression of TS, TP and DPD in tumor tissues and response
- measure
- Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic cancer * Stage IV disease * Measurable disease (≥ 1 cm or \> 10 mm lesion(s) by spiral CT scan) * Disease progression after ≥ 1 gemcitabine-based treatment regimen for advanced/metastatic disease * Patient carries the double tandem repeat (S/S) variant of the thymidylate synthase gene enhancer region (TSER) * No active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if attributable to liver metastases) * Total bilirubin ≤ 1.5 times ULN * Creatinine normal OR creatinine clearance \> 50 mL/min * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * Not pregnant or nursing * Negative pregnancy test * Asymptomatic HIV infection allowed * No recent or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, bleeding, inflammation, emesis, or diarrhea \> grade 1) * Able to swallow capecitabine tablets * No known hypersensitivity to fluorouracil * No dihydropyrimidine dehydrogenase (DPD) deficiency * No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) * No myocardial infarction within the past 6 months * No serious, uncontrolled, concurrent infection(s) * No prior unanticipated severe reaction to fluoropyrimidine therapy * No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior capecitabine except in the adjuvant setting * At least 3 weeks since prior radiotherapy or major surgery * At least 4 weeks since prior participation in any investigational drug study * At least 4 weeks since prior sorivudine or brivudine * No concurrent sorivudine or brivudine * No concurrent cimetidine or azidothymidine (AZT) * Concurrent radiotherapy for bone pain allowed to a limited field provided ≥ 1 indicator lesion remains outside of the field * No other concurrent chemotherapy or immunotherapy
References
Publications (0)
Data not yet available