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

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

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


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.

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

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer therapies

Type of Study:


Study Design:

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

Outcome Measure:

Response rate as measured by RECIST criteria

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Hedy Kindler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

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



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470