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A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer

A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma

NCT01025570•University of California, San Francisco

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven adenocarcinoma of the pancreas.
•Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
•No measurable disease.
•ECOG performance status 0 - 1.
•≥ 18 years of age.
•Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
•CA 19-9 ≤ 2.5 times the upper limit of normal.
•ANC (absolute neutrophil count) ≥ 1500/μL
•Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
•Platelet count ≥ 100,000/μL
+8 more criteria

Exclusion Criteria

•Any prior systemic or investigational therapy for pancreatic cancer.
•Grossly positive surgical margins.
•Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
•History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
•Serious active ongoing infection, including any requiring parenteral antibiotics.
•Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
•Pregnancy (positive pregnancy test) or lactation.
•Known central nervous system disease.
•Inability to swallow pills/tolerate oral intake.
•Inability to comply with study and/or follow-up procedures.

Locations (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

May 1, 2012

Completion Date

June 1, 2013

Last Updated

May 9, 2014

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Gemcitabine, Bosutinib

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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: May 9, 2014Data 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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A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

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