Clinical trial NCT00095966: Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official title: A Phase II Study of BAY 43-9006/Gemcitabine for Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-11-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate as measured by RECIST criteria
timeFrame: Up to 6 months
Secondary outcomes:
measure: Progression free survival
timeFrame: From start of treatment to progression or death, assessed up to 6 months
measure: Survival
timeFrame: At 6 months
measure: Overall survival
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Hedy Kindler
role: PRINCIPAL_INVESTIGATOR
References: