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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01045538
Collaborator
(none)
45
1
1
74
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vorinostat, capecitabine, and cisplatin
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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
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
Other Names:
  • Zolinza, and xeloda
  • Outcome Measures

    Primary Outcome Measures

    1. Phase 1 - maximum tolerated dose, Phase 2 - response rate [3 weeks for maximum tolerated dose, and 6 months for response rate]

    Secondary Outcome Measures

    1. Toxicity profile [toxicity for each cycle]

    2. Progression-free survival [1 year]

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

    3. Overall survival [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yoon-Koo Kang, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT01045538
    Other Study ID Numbers:
    • AMC0903
    First Posted:
    Jan 11, 2010
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by Yoon-Koo Kang, Professor, Asan Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 7, 2020