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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

Primary Purpose

Gastric Cancer, Histone Deacetylase Inhibitor

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vorinostat, capecitabine, and cisplatin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, histone deacetylase inhibitor, 1st line chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vorinostat plus XP

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity profile
Progression-free survival
Time from first administration of study drug to disease progression or any cause of death
Overall survival
Time from first administration of study drug to any cause of death

Full Information

First Posted
January 6, 2010
Last Updated
January 6, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01045538
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Histone Deacetylase Inhibitor
Keywords
gastric cancer, histone deacetylase inhibitor, 1st line chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vorinostat plus XP
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Vorinostat, capecitabine, and cisplatin
Other Intervention Name(s)
Zolinza, and xeloda
Intervention Description
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
Primary Outcome Measure Information:
Title
Phase 1 - maximum tolerated dose, Phase 2 - response rate
Time Frame
3 weeks for maximum tolerated dose, and 6 months for response rate
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
toxicity for each cycle
Title
Progression-free survival
Description
Time from first administration of study drug to disease progression or any cause of death
Time Frame
1 year
Title
Overall survival
Description
Time from first administration of study drug to any cause of death
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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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

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