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

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Gemcitabine, Bosutinib

09456
10-00560 (OTHER Identifier) (OTHER: UCSF CHR-approval number)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-05-07
First Submitted that Met QC Criteria 2009-12-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-05-09
First Posted (ESTIMATED) 2009-12-03	Results First Posted N/A	Last Verified 2014-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gem/Bos Gemcitabine 1000 mg/m2, D1,8,15 of each cycle Bostutinib 400 mg daily concurrently with Gemcitabine	DRUG: Gemcitabine, Bosutinib Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gem/Bos

Gemcitabine 1000 mg/m2, D1,8,15 of each cycle Bostutinib 400 mg daily concurrently with Gemcitabine

DRUG: Gemcitabine, Bosutinib

Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily

Primary Outcome Measures	Measure Description	Time Frame
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.		8 weeks after the 6th patient is enrolled
To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination		2 years after last patient is enrolled

Secondary Outcome Measures	Measure Description	Time Frame
To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib		2 years after last patient is enrolled
To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination		2 years after last patient is enrolled

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
Total bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 2.5 times the upper limit of normal
Serum creatinine ≤ 2.0
Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

University of Utah

Investigators

PRINCIPAL_INVESTIGATOR: Andrew H. Ko, MD, University of California, San Francisco

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record