Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gemcitabine

Cisplatin

Cyclooxygenase 2 Inhibitors

Rofecoxib

Antimetabolites

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.

Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.

gemcitabine

prolonged continuous infusion gemcitabine

cisplatin

rofecoxib

Cesare Gridelli, M.D.

Francesco Perrone, M.D., Ph.D.

The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.

The primary end-points of the GECO study

* To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC
* To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC
* To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced NSCLC

Four treatment arms are planned.

* ARM A standard treatment : cisplatin + gemcitabine
* ARM B cisplatin + gemcitabine + rofecoxib
* ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute)
* ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib

The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms.

The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of

* The efficacy of rofecoxib: A + C (arms without rofecoxib) vs B+D (arms with rofecoxib)
* The efficacy of p.c.i. gemcitabine: A + B (arms with standard infusion of gemcitabine) vs C+ D (arms with p.c.i gemcitabine)

Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

Phase II-III, Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polycht With Cispatin and Gemcitabine and Fixed Dose Rate Infusion of Gem in Association With Cisplatin in 1st-line for Advanced NSCLC

adverse events according to CTCAE criteria

response rate according to RECIST criteria

National Cancer Institute, Naples

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Comparator: placebo (unspecified)

Medical Monitor

To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.

Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)

Merck Sharp & Dohme LLC

Digestive System Diseases

Rare Diseases

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Oculocerebral Syndrome With Hypopigmentation

Gastrointestinal Agents

Antipyretics

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Vasoconstrictor Agents

Respiratory System Agents

Cardiotonic Agents

Reproductive Control Agents

Esomeprazole

Aspirin

Oxymetazoline

Phenylephrine

Dinoprostone

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Paula Fernstrom

This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.

Barrett's Esophagus - 315 - 3 Way Cross Over

A Multicenter, Open-label, Four-way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus

AstraZeneca

Tore Lind, MD - Nexium Medical Science Director

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Adenomatous Polyposis Coli

Polyps

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Familial Adenomatous Polyposis

MYH-associated Polyposis

placebo

Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.

Coxib-inhibition of Duodenal Polyp Growth in FAP

Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis

Oslo University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC	NCT00385606	Advanced Non-sm...	gemcitabine prolonged conti... cisplatin rofecoxib	18 Years - 70 Years	National Cancer Institute, Naples
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)	NCT00060476	Prostate Cancer	rofecoxib Comparator: pla...	50 Years - 75 Years	Merck Sharp & Dohme LLC
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC	NCT00385606	Advanced Non-sm...	gemcitabine prolonged conti... cisplatin rofecoxib	18 Years - 70 Years	National Cancer Institute, Naples
Barrett's Esophagus - 315 - 3 Way Cross Over	NCT00637988	Barrett's Esoph...	Esomeprazole Aspirin Rofecoxib	18 Years -	AstraZeneca
Coxib-inhibition of Duodenal Polyp Growth in FAP	NCT00844727	Duodenal Polypo...	Rofecoxib placebo	18 Years - 70 Years	Oslo University Hospital

Spots Global Cancer Trial Database for rofecoxib

Every month we try and update this database with for rofecoxib 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.

Spots Global Cancer Trial Database for rofecoxib

Every month we try and update this database with for rofecoxib 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.

Every month we try and update this database with for rofecoxib 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.