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

This study is currently recruiting participants.
Verified August 2012 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01045538
First received: January 6, 2010
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Gastric Cancer
Histone Deacetylase Inhibitor
 Drug: Vorinostat, capecitabine, and cisplatin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Phase 1 - maximum tolerated dose, Phase 2 - response rate [ Time Frame: 3 weeks for maximum tolerated dose, and 6 months for response rate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: toxicity for each cycle ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time from first administration of study drug to disease progression or any cause of death

  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time from first administration of study drug to any cause of death


Estimated Enrollment: 45
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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 Name: Zolinza, and xeloda
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045538

Contacts
Contact: Yoon-Koo Kang, M.D., Ph.D. 82-2-3010-3210 ykkang@amc.seoul.kr
Contact: Min-Hee Ryu, M.D. 82-2-30105935 miniryu@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yoon-Koo Kang, M.D., Ph.D.     82-2-3010-3210     ykkang@amc.seoul.kr    
Principal Investigator: Yoon-Koo Kang, M.D.,Ph.D.            
Sponsors and Collaborators
Asan Medical Center
  More Information

Publications:

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01045538     History of Changes
Other Study ID Numbers: AMC0906
Study First Received: January 6, 2010
Last Updated: August 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
gastric cancer
histone deacetylase inhibitor
1st line chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Vorinostat
Cisplatin
Fluorouracil
 Histone Deacetylase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013