Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

6. Other events that, based upon appropriate medical judgement, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes

Taxoprexin

Mark A Falone, MD

The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.

Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

A Phase III, Randomized, Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

To compare the overall survival of patients with advanced NSCLC treated with either weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • To compare the safety and tolerability of weekly Taxoprexin® in combination with carboplatin every 3 weeks with paclitaxel and carboplatin administered every 3 weeks.

To compare time to progression (TTP), time to treatment failure (TTF) and one-year survival in patients with advanced NSCLC treated with weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • To compare the objective response rates (ORR) and duration of response in patients with advanced NSCLC treated with either weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • Formal pharmacokinetics (PK) were to be done at selected sites for 18 patients randomized to treatment Arm A

American Regent, Inc.

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

To evaluate objective response rate and duration of response to weekly Taxoprexin®.

To evaluate the safety profile of weekly Taxoprexin® in this patient population.

To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin® Injection.

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents including IL-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Taxoprexin Treatment for Advanced Skin Melanoma

Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Gallbladder Cancer

Hematinics

Liver Extracts

Bilirubin

Starting dose of 500 mg/m2 (400 mg/m2 for patients with an elevated bilirubin at baseline) administered intravenously by a 1-hour infusion weekly for the first 5 weeks of a 6 week cycle.

Ahmed Kaseb, M.D.

To evaluate objective response rate and duration of response to weekly Taxoprexin®.

To evaluate the safety profile of weekly Taxoprexin® in this patient population.

To evaluate overall survival in the same patient population.

To evaluate time to disease progression, and the time to treatment failure in patients with primary liver cancer being treated with weekly Taxoprexin® Injection.

To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with advanced primary cancers of the liver, including hepatocellular carcinoma (HCC), or carcinoma of the gallbladder or biliary tract (BTC), who have not received prior systemic cytotoxic therapy for advanced disease. Patients may have previously received radiation and/or systemic chemotherapy as adjuvant therapy. Patients may not have been treated previously with a taxane. Patients may have been previously treated with up to two immunological and/or biologic agents (e.g., interferon, monoclonal antibodies, tyrosine kinase inhibitors). Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 (400mg/m2 for patients with an elevated bilirubin at baseline) intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Taxoprexin® Treatment for Advanced Primary Cancers of the Liver

Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Second Line Therapy for Patients With Advanced Primary Cancers of the Liver, Including Hepatocellular Carcinoma and Carcinoma of the Gallbladder or Biliary Tract

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer	NCT00243867	Non-Small Cell ...	Taxoprexin	18 Years -	American Regent, Inc.
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer	NCT00243867	Non-Small Cell ...	Taxoprexin	18 Years -	American Regent, Inc.
Taxoprexin Treatment for Advanced Skin Melanoma	NCT00249262	Metastatic Mela...	Taxoprexin	13 Years -	American Regent, Inc.
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver	NCT00422877	Cancer of the L...	Taxoprexin	18 Years -	American Regent, Inc.
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer	NCT00243867	Non-Small Cell ...	Taxoprexin	18 Years -	American Regent, Inc.

Spots Global Cancer Trial Database for taxoprexin

Every month we try and update this database with for taxoprexin 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 taxoprexin

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