Sorafenib And Gemcitabine In Treating Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with sorafenib and gemcitabine. II. Determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with sorafenib plus gemcitabine. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 7 months.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: sorafenib tosylate
DRUG: gemcitabine hydrochloride

NCI-2012-02629
13169B
CDR0000391850
NCI-6567
UCCRC-13169B
U01CA099118 (U.S. NIH Grant/Contract)
N01CM62201 (U.S. NIH Grant/Contract)

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 2004-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-07-01
First Submitted that Met QC Criteria 2004-11-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-07-02
First Posted (ESTIMATED) 2004-11-09	Results First Posted N/A	Last Verified 2013-07

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: Treatment (sorafenib tosylate and gemcitabine hydrochloride) Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	DRUG: sorafenib tosylate Given orally DRUG: gemcitabine hydrochloride Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (sorafenib tosylate and gemcitabine hydrochloride)

Patients receive oral sorafenib twice daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

DRUG: sorafenib tosylate

Given orally

DRUG: gemcitabine hydrochloride

Given IV

Primary Outcome Measures	Measure Description	Time Frame
Response rate as measured by RECIST criteria		Up to 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival	Kaplan-Meier curves will be constructed.	From start of treatment to progression or death, assessed up to 6 months
Survival	Specific attention will be given to the six-month survival rate, for which 90% confidence intervals will be generated.	At 6 months
Overall survival	Kaplan-Meier curves will be constructed	Up to 6 months

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 or cytologically confirmed adenocarcinoma of the pancreas

Locally advanced or metastatic disease

Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
Not amenable to curative surgery or radiotherapy
Measurable disease

At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Pleural effusion and ascites are not considered measurable lesions
Outside prior radiotherapy port
No known brain metastases
Performance status - ECOG 0-1
Performance status - Karnofsky 70-100%
More than 3 months
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No evidence of bleeding diathesis
Bilirubin normal
AST and/or ALT ≤ 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
No uncontrolled hypertension
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active or ongoing infection
No other active malignancy
No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
No prior antiangiogenic agents
No prior cytotoxic chemotherapy for metastatic disease
At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No prior gemcitabine
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No prior investigational drugs
No prior sorafenib
No prior MAPK signaling agents
Concurrent warfarin anticoagulation allowed provided the following criteria are met:

Therapeutic on a stable warfarin dose
INR ≤ 3
Undergo weekly INR testing
No active bleeding or pathological condition that carries a high risk of bleeding
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapies

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Hedy Kindler, University of Chicago Comprehensive Cancer Center

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

Learn

Resources

PatientS

Caregivers

Clinical Trial Record