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 January 2014 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: January 13, 2014
Last verified: January 2014

January 6, 2010
January 13, 2014
February 2010
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01045538 on ClinicalTrials.gov Archive Site
  • 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
Toxicity profile, Progression-free survival, Overall survival [ Time Frame: toxicity for each cycle, progression or survial for 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Cancer
  • Histone Deacetylase Inhibitor
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
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
Intervention: Drug: Vorinostat, capecitabine, and cisplatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT01045538
AMC-ONCGI-0903
Yes
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
Not Provided
Not Provided
Asan Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP