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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer, Histone Deacetylase Inhibitor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 weeks for maximum tolerated dose, and 6 months for response rate

Safety Issue:

Yes

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC0906

NCT ID:

NCT01045538

Start Date:

February 2010

Completion Date:

December 2012

Related Keywords:

  • Gastric Cancer
  • Histone Deacetylase Inhibitor
  • gastric cancer
  • histone deacetylase inhibitor
  • 1st line chemotherapy
  • Stomach Neoplasms

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