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A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer



- To determine the efficacy of sorafenib tosylate in combination with erlotinib
hydrochloride in patients with unresectable pancreatic cancer.


- To determine the response rate in patients treated with this regimen.

- To determine the progression-free survival of patients treated with this regimen at 4

- To evaluate the safety profile of this regimen in these patients.

- To evaluate the change in serum Ca 19-9 levels at baseline and at 8-week intervals.

- To evaluate the plasma proteomic profile at baseline and at 8 weeks to correlate with
clinical parameters in order to identify potential prognostic or predictive markers.

- To analyze single-nucleotide polymorphisms on DNA obtained from pretreatment blood
samples to evaluate toxicity and response to erlotinib hydrochloride.

OUTLINE: Patients receive oral sorafenib tosylate once or twice daily and oral erlotinib
hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.

Serum samples are collected at baseline and at 8-week intervals to measure Ca 19-9 levels,
and plasma and buffy coat samples are collected at baseline and at week 8 for proteomic
assessment and genotyping of single-nucleotide polymorphisms associated with response and
toxicity to erlotinib hydrochloride.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria


- Microscopically confirmed diagnosis of pancreatic adenocarcinoma

- Unresectable disease

- No neuroendocrine tumors or cystadenocarcinoma

- Measurable or evaluable disease by RECIST criteria

- No known brain metastases

- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to
exclude brain metastases


- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)

- Creatinine ≤ 1.5 times ULN

- INR < 1.5 or PT/PTT normal unless patients are receiving anticoagulation treatments

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception before, during, and for at
least 6 months after completion of study treatment

- Able to swallow whole pills

- No patients who currently smoke

- No cardiac disease, including any of the following:

- NYHA class III-IV congestive heart failure

- Unstable angina (anginal symptoms at rest)

- New-onset angina (began within the past 3 months)

- Myocardial infarction within the past 6 months

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- No uncontrolled hypertension defined as systolic BP > 150 mm Hg or diastolic BP > 90
mm Hg despite optimal medical management

- No arterial thrombotic or embolic events (e.g., cerebrovascular accident, including
transient ischemic attacks) within the past 6 months

- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 in the past 4 weeks

- No other hemorrhage/bleeding event ≥ CTCAE grade 3 in the past 4 weeks

- No significant traumatic injury in the past 4 weeks

- No known untreated malabsorption problem (e.g., ulcerative colitis, Crohn's disease)

- No known HIV positivity or chronic hepatitis B or C

- No known or suspected allergy to sorafenib tosylate or erlotinib hydrochloride

- No active clinically serious infection > CTCAE grade 2

- No serious non-healing wound, ulcer, or bone fracture

- No evidence or history of bleeding diathesis or coagulopathy (except for
cancer-related blood clots)

- No dermatitis ≥ CTCAE grade 2 at baseline

- No patients who currently smoke


- No prior treatment with antiangiogenics (e.g., bevacizumab, thalidomide, marimastat,
interferon alfa, vatalanib, vandetanib, ZD6126, sorafenib, semaxanib, sunitinib,

- No more than one line of prior therapy for metastatic disease

- More than 4 weeks since prior major surgery or open biopsy

- No concurrent strong CYP34A inhibitors or inducers

- Concurrent warfarin or heparin allowed with the approval of the principal

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Progression-free Survival

Outcome Description:

Number of patients with progression-free survival at 8 weeks

Outcome Time Frame:

at 8 weeks

Safety Issue:


Principal Investigator

Jordan D. Berlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 0815



Start Date:

October 2008

Completion Date:

May 2013

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Erlanger Cancer Center at Erlanger Hospital - Baroness Chattanooga, Tennessee  37403
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at Franklin Nashville, Tennessee  37064
Purchase Cancer Group - Paducah Paducah, Kentucky  42001
Baptist Regional Cancer Center at Baptist Riverside Knoxville, Tennessee  37901