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BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer

BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer: A Phase I Study #108181

NCT00447122•Brown University

View on ClinicalTrials.gov

Summary

Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

Detailed Description

To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients are required to have histologically or pathologically confirmed, metastatic adenocarcinoma of the pancreas
•No prior chemotherapy for pancreatic cancer.
•ECOG performance status 0-1
•Must retain ability to swallow oral medications
•Age \> 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients \< 18 years of age, children are excluded from this study.
•Women of child bearing potential must be non pregnant and non lactating.The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female is eligible to enter and participate in the study if she is of:
•* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
•* Has had a hysterectomy,
•* Has had a bilateral oophorectomy (ovariectomy),
•* Has had a bilateral tubal ligation, or
+13 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•Prior treatment with lapatinib or any EGFR targeting therapies.
•Prior treatment with systemic chemotherapy for pancreatic cancer.
•Clinical evidence of brain metastases or leptomeningeal disease
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Active cardiac disease, defined as:
•* History of uncontrolled angina
•* Myocardial infarction \< 6 months from study entry
•* Uncontrolled or symptomatic congestive heart failure
•* Ejection fraction below the institutional normal limit
+12 more criteria

Locations (1)

Lifespan Hospitals

Providence, Rhode Island, United States

Key Dates

Start Date

March 1, 2007

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

March 8, 2022

Enrollment

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Gemcitabine 1000mg/m2 30 minutes

DRUG

Lapatinib 1000mg/d

DRUG

Lapatinib 1500mg/d

DRUG

Gemcitabine 1000mg/m2 100minutes

DRUG

Oxaliplatin 100mg/m2

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BrUOG-PA-209: Lapatinib and Gemcitabine for Metastatic Pancreaticobiliary Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer