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Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer

NCT01010945•OSI Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

Detailed Description

This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
•Predicted life expectancy of \>= 12 weeks
•Previous surgery
•Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
•No prior therapy for pancreatic cancer
•Adequate organ and marrow function
•* Absolute neutrophil count \>= 1.5 x 10\^9/L
•* Platelets \>= 100 x 10\^9/L
•* Total bilirubin \<= institutional upper limits of normal
•* AST (SGOT)/ALT(SGPT) \<= 2 x institutional upper limits of normal
+4 more criteria

Exclusion Criteria

•Significant history of cardiac disease unless the disease is well controlled
•Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
•History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
•History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
•Pregnant or breast-feeding females
•Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
•History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs

Locations (5)

Desert Comprehensive Cancer Center

Palm Springs, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

Key Dates

Start Date

February 3, 2010

Primary Completion Date

January 25, 2012

Completion Date

January 25, 2012

Last Updated

November 21, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Pancreatic Cancer

Interventions

erlotinib

DRUG

gemcitabine

DRUG

nab-paclitaxel

DRUG

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

NCT03652428

Locally Advanced Pancreatic Cancer

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RECRUITINGEARLY_PHASE1

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NCT05098197

Advanced Liver CancersTumor Infiltrating Lymphocyte+3 more

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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: November 21, 2024Data 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.

View ClinicalTrials.gov Terms and Conditions

Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Olaparib in PALB2 Advanced Pancreatic Cancer

Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies