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

Stage IV Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095966
• Other study ID #: NCI-2012-02629
• Secondary ID: 13169BCDR0000391
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: July 1, 2013
• Start date: September 2004

Study information

• Verified date: July 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• sorafenib tosylate
Given orally
• gemcitabine hydrochloride
Given IV

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by RECIST criteria		Up to 6 months	No
Secondary	Progression free survival	Kaplan-Meier curves will be constructed.	From start of treatment to progression or death, assessed up to 6 months	No
Secondary	Survival	Specific attention will be given to the six-month survival rate, for which 90% confidence intervals will be generated.	At 6 months	No
Secondary	Overall survival	Kaplan-Meier curves will be constructed	Up to 6 months	No