Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cisplatin

Vorinostat

Histone Deacetylase Inhibitors

Antimetabolites

Enzyme Inhibitors

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

Vorinostat, capecitabine, and cisplatin

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.

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

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

Time from first administration of study drug to disease progression or any cause of death

Time from first administration of study drug to any cause of death

Asan Medical Center

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gemcitabine

Vaccines

Immunomodulating Agents

MVA-MUC1-IL2 in combination with 1st line Chemotherapy

1st line Chemotherapy without a MVA-MUC1-IL2 combination

MVA-MUC1-IL2:

Dose of 10exp8 plaque forming units (pfu).

Chemotherapy:

Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first.

MVA-MUC1-IL2

1st line Chemotherapy

Elisabeth QUOIX, M.D.

The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.

In the experimental arm patients receive subcutaneous injections of TG4010 at the dose of 108 pfu in combination with chemotherapy treatment whereas patients in the control arm receive chemotherapy alone. The chemotherapy associates cisplatin and gemcitabine and is given for up to 6 cycles or progressive disease, whichever occurs first.

TG4010 is administered once per week for 6 weeks, then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease.

Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks. The tumor response taken into account will be for each patient the best overall response obtained during the study.

The endpoint of the study is based on Progression Free Survival (PFS) at 6 months.

Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer

A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer

Transgene

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP	NCT01045538	Gastric Cancer Histone Deacety...	Vorinostat, cap...	18 Years -	Asan Medical Center
Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP	NCT01045538	Gastric Cancer Histone Deacety...	Vorinostat, cap...	18 Years -	Asan Medical Center
Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer	NCT00415818	Carcinoma, Non-...	MVA-MUC1-IL2 1st line Chemot...	18 Years -	Transgene

Spots Global Cancer Trial Database for 1st line chemotherapy