Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Oxaliplatin

Lapatinib

Weekly gem + GW572016, 1000mg/day (combination)

Weekly gem + GW572016, 1500 mg/day (combination)

GEMOX + GW572016 1000 mg/day (combination)

GEMOX + GW572016 1500 mg/day (combination)

cohort 1

cohort 2

cohort 3

cohort 4

howard Safran, MD

A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.

Trial finished and no further data will be collected.

A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema

BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556

To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs

To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.

GlaxoSmithKline

Brown University

Principal Investigator

Cohort 1: Weekly gem + GW572016, 1000mg/day.

Cohort 1

Cohort 2: Weekly gem + GW572016, 1500 mg/day.

Cohort 2

Cohort 3

Cohort 4

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

participant number correlates to all enrolled patients treated on this study as a whole which is the way in which the abstract was written and therefore how these results are entered

Howard Safran, MD

Cohorts 1

Toxicity (Number of Patients Who Experiened DLTs)

Number of Patients Who Experienced a Partial Response

Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)

Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)

Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)

Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)

Spots Global Cancer Trial Database for cohort 4

Every month we try and update this database with for cohort 4 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 cohort 4

Every month we try and update this database with for cohort 4 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 cohort 4 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.