Clinical trial · Interventional
Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP
A Phase I/II Study of Vorinostat (Zolinza®) in Combination With Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer
NCT01045538CI-TRIAL-00042638completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
There is scientific rationale for exploring the role of vorinostat, histone deacetylase inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC) and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and angiogenesis through histone deacetylase inhibition.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Histone Deacetylase Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorinostat, capecitabine, and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat plus XP
- description
- Vorinostat 200\~400mg per day on day1-day14 combined with capecitabine 800-1,000mg/m2/dose, BID on day1-day14, and cisplatin 60-80mg/m2 on day 1
- interventionNames
- Drug: Vorinostat, capecitabine, and cisplatin
Primary outcomes (1)
- measure
- Phase 1 - maximum tolerated dose, Phase 2 - response rate
- timeFrame
- 3 weeks for maximum tolerated dose, and 6 months for response rate
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- toxicity for each cycle
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma * Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy * Age 18 to 70 years old * Eastern Cooperative Oncology Group (ECOG) performance status 2 or less * Estimated life expectancy of more than 3 months * Presence of measurable or evaluable disease * Adequate bone marrow function (ANC \>1,500/µL and platelets\>100,000/µL), * Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance 60ml/min or less * Adequate hepatic function: bilirubin \< 1.5 x UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels \< 2.5 x UNL (\< 5 x upper limit of normal for patients with liver involvement of their cancer), alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease) * Written informed consent Exclusion Criteria: * Prior exposure to any histone deacetylase (HDAC) inhibitor (however, valproic acid would be allowed if a 30-day wash-off period is provided.) * Previous adjuvant treatment with capecitabine or platinums * Contraindication to any drug contained in the chemotherapy regimen * Other tumor type than adenocarcinoma * Presence or history of central nervous system (CNS) metastasis * Gastric outlet or bowel obstruction * Evidence of serious gastrointestinal bleeding * Peripheral neuropathy \> grade 2 * History of significant neurologic or psychiatric disorders * History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Active human immunodeficiency virus (HIV) infection * Viral hepatitis infections * Other serious illness or medical conditions
References
Publications (12)
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- BACKGROUNDCassidy J, Dirix L, Bissett D, Reigner B, Griffin T, Allman D, Osterwalder B, Van Oosterom AT. A Phase I study of capecitabine in combination with oral leucovorin in patients with intractable solid tumors. Clin Cancer Res. 1998 Nov;4(11):2755-61. PMID 9829739
- BACKGROUNDGlimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668. PMID 9093725
- BACKGROUNDHansen RM. 5-Fluorouracil by protracted venous infusion: a review of recent clinical studies. Cancer Invest. 1991;9(6):637-42. doi: 10.3109/07357909109039875. PMID 1747791
- BACKGROUNDHong YS, Song SY, Lee SI, Chung HC, Choi SH, Noh SH, Park JN, Han JY, Kang JH, Lee KS, Cho JY. A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. Ann Oncol. 2004 Sep;15(9):1344-7. doi: 10.1093/annonc/mdh343. PMID 15319239
- BACKGROUNDKim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5. PMID 8508349
- BACKGROUNDKim TW, Kang YK, Ahn JH, Chang HM, Yook JH, Oh ST, Kim BS, Lee JS. Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol. 2002 Dec;13(12):1893-8. doi: 10.1093/annonc/mdf323.