Clinical trial NCT01045538: Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Histone Deacetylase Inhibitor
Keywords: gastric cancer
histone deacetylase inhibitor
1st line chemotherapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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:
measure: Toxicity profile
timeFrame: toxicity for each cycle
measure: Progression-free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
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