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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00537121 |
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced upper gastrointestinal cancer.
Condition | Intervention | Phase |
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Esophageal Cancer Gastric Cancer Liver Cancer |
Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: vorinostat Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of Vorinostat [Suberoylanilide Hydroxamic Acid (VORINOSTAT)] With Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (FOLFIRI) for Advanced Upper Gastrointestinal Cancers |
Estimated Enrollment: | 25 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 (FOLFIRI). Patients also receive oral vorinostat (SAHA) according to 1 of the following dosing regimens outlined below, depending upon time of study entry:
Some patients undergo tumor tissue and blood sample collection periodically for pharmacokinetic and correlative studies. Tumor tissue samples are assessed for TGF-β expression by immunohistochemical methods and by reverse transcriptase-polymerase chain reaction for mRNA expression. Immunohistochemistry and immunoenzymatic techniques are performed to study survivin expression before beginning treatment and after completion of course 1.
Pharmacokinetic studies for irinotecan, SN38, and SN38G are obtained on days 1 (before SAHA) and 15 (after SAHA).
Blood is also collected for analysis of UGT1A1 polymorphism. Other patients undergo blood collection on days -7 (before FOLFIRI) and 2 (with FOLFIRI) for vorinostat Pharmacokinetic studies. Samples are analyzed by liquid chromatography-mass spectrometry.
After completion of study treatment, patients are followed for 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed upper gastrointestinal tract cancer, including any of the following:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Nikhil Khushalani, MD 716-845-7614 |
Principal Investigator: | Nikhil Khushalani, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000564857, RPCI-I-78806 |
Study First Received: | September 27, 2007 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00537121 History of Changes |
Health Authority: | Unspecified |
recurrent gastric cancer stage IV gastric cancer recurrent esophageal cancer stage IV esophageal cancer adenocarcinoma of the esophagus adenocarcinoma of the stomach squamous cell carcinoma of the esophagus |
adult primary hepatocellular carcinoma stage III gastric cancer stage III esophageal cancer advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Liver Diseases Immunologic Factors Gastrointestinal Diseases Carcinoma, Hepatocellular Esophageal Neoplasms Irinotecan Leucovorin Squamous Cell Carcinoma Liver Neoplasms Stomach Diseases Vitamins Stomach Neoplasms |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Micronutrients Hepatocellular Carcinoma Vitamin B Complex Digestive System Neoplasms Vorinostat Trace Elements Esophageal Cancer Folinic Acid Immunosuppressive Agents Camptothecin Recurrence Carcinoma Calcium, Dietary |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Irinotecan Leucovorin Liver Neoplasms Stomach Diseases |
Neoplasms by Site Sensory System Agents Vitamins Stomach Neoplasms Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Vorinostat Enzyme Inhibitors Protective Agents Immunosuppressive Agents |