Neoplasms

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Gastrointestinal Diseases

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All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Tacedinaline

Antimetabolites

Histone Deacetylase Inhibitors

Enzyme Inhibitors

gemcitabine hydrochloride

tacedinaline

Kathy M. Diener, PharmD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced pancreatic cancer.

OBJECTIVES: I. Determine the efficacy and safety of CI-994 given in combination with gemcitabine compared to gemcitabine alone in the treatment of patients with advanced pancreatic cancer.

OUTLINE: Gemcitabine is the standard of care for pancreatic cancer and is administered by intravenous injection. Patients receive gemcitabine once a week for 3 weeks followed by 1 week of rest. Patients take the capsules (placebo or investigational chemotherapy) daily for 21 consecutive days beginning with the first gemcitabine infusion. The duration of treatment is determined by the patient's tolerance of therapy and the assessment of disease response.

PROJECTED ACCRUAL: A total of 172 patients will be enrolled in Canada, Europe, and the United States on a competitive basis.

Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion in the Treatment of Patients With Advanced Pancreatic Cancer

Pfizer

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Kathryn Kimmel, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine plus CI-994 is more effective than gemcitabine alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without CI-994 in treating patients who have advanced non-small cell lung cancer.

OBJECTIVES: I. Determine the efficacy and safety of gemcitabine with or without CI-994 in patients with advanced non-small cell lung cancer.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to performance status and are randomized to one of two treatment arms. Arm I: Patients receive CI-994 orally on days 1-21 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Arm II: Patients receive placebo capsules orally on days 1-21 and gemcitabine as in arm I. Treatment repeats every 28 days as long as medically appropriate (absence of disease progression or unacceptable toxicity).

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer

A Randomized Double-Blind, Placebo-Controlled, Multicenter Study of CI-994 Capsules Plus Gemcitabine Infusion Versus Placebo Capsules Plus Gemcitabine Infusion as Second-Line Treatment of Patients With Advanced Nonsmall Cell Lung Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer	NCT00004861	Pancreatic Canc...	gemcitabine hyd... tacedinaline	18 Years -	Pfizer
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Non-small Cell Lung Cancer	NCT00005093	Lung Cancer	gemcitabine hyd... tacedinaline	18 Years -	Pfizer
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer	NCT00004861	Pancreatic Canc...	gemcitabine hyd... tacedinaline	18 Years -	Pfizer

Spots Global Cancer Trial Database for tacedinaline

Every month we try and update this database with for tacedinaline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.