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CompletedNCT01045538Updated Jan 7, 2020

Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP

A Phase 1/2 interventional study of Vorinostat, capecitabine, and cisplatin in Gastric Cancer and Histone Deacetylase Inhibitor, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Asan Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Gastric Cancer
  • Histone Deacetylase Inhibitor

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Keywords

  • gastric cancer
  • histone deacetylase inhibitor
  • 1st line chemotherapy
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 45 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Vorinostat plus XP

    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

    Drug: Vorinostat, capecitabine, and cisplatin

Interventions

  • DrugVorinostat, capecitabine, and cisplatin

    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

    Also known as: Zolinza, and xeloda

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What researchers measure

Primary outcomes

  1. Phase 1 - maximum tolerated dose, Phase 2 - response rate

    Time frame: 3 weeks for maximum tolerated dose, and 6 months for response rate

Secondary outcomes

  1. Toxicity profile

    Time frame: toxicity for each cycle

  2. Progression-free survival

    Time from first administration of study drug to disease progression or any cause of death

    Time frame: 1 year

  3. Overall survival

    Time from first administration of study drug to any cause of death

    Time frame: 1 year

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Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

References and documents

Publications

  • Budman DR, Meropol NJ, Reigner B, Creaven PJ, Lichtman SM, Berghorn E, Behr J, Gordon RJ, Osterwalder B, Griffin T. Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol. 1998 May;16(5):1795-802. doi: 10.1200/JCO.1998.16.5.1795. PubMed 9586893 ↗
  • Cassidy 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. PubMed 9829739 ↗
  • Glimelius 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. PubMed 9093725 ↗
  • Hansen RM. 5-Fluorouracil by protracted venous infusion: a review of recent clinical studies. Cancer Invest. 1991;9(6):637-42. doi: 10.3109/07357909109039875. PubMed 1747791 ↗
  • Hong 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. PubMed 15319239 ↗
  • Kim 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. PubMed 8508349 ↗
  • Kim 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. PubMed 12453857 ↗
  • Koizumi W, Saigenji K, Ujiie S, Terashima M, Sakata Y, Taguchi T; Clinical Study Group of Capecitabine. A pilot phase II study of capecitabine in advanced or recurrent gastric cancer. Oncology. 2003;64(3):232-6. doi: 10.1159/000069313. PubMed 12697963 ↗
  • Kurdistani SK. Histone modifications as markers of cancer prognosis: a cellular view. Br J Cancer. 2007 Jul 2;97(1):1-5. doi: 10.1038/sj.bjc.6603844. Epub 2007 Jun 26. PubMed 17592497 ↗
  • Mann BS, Johnson JR, Cohen MH, Justice R, Pazdur R. FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma. Oncologist. 2007 Oct;12(10):1247-52. doi: 10.1634/theoncologist.12-10-1247. PubMed 17962618 ↗
  • Park YS, Jin MY, Kim YJ, Yook JH, Kim BS, Jang SJ. The global histone modification pattern correlates with cancer recurrence and overall survival in gastric adenocarcinoma. Ann Surg Oncol. 2008 Jul;15(7):1968-76. doi: 10.1245/s10434-008-9927-9. Epub 2008 May 10. PubMed 18470569 ↗
  • Weichert W, Roske A, Gekeler V, Beckers T, Ebert MP, Pross M, Dietel M, Denkert C, Rocken C. Association of patterns of class I histone deacetylase expression with patient prognosis in gastric cancer: a retrospective analysis. Lancet Oncol. 2008 Feb;9(2):139-48. doi: 10.1016/S1470-2045(08)70004-4. PubMed 18207460 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01045538
Lead sponsor
Asan Medical Center
Responsible party
Yoon-Koo Kang (Professor, Asan Medical Center) — Principal investigator
First posted
Jan 11, 2010
Start date
Feb 2010
Primary completion
Feb 2016
Completion
Apr 2016
Last update
Jan 7, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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