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A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer



- Evaluate the 6-month overall survival rate in patients with gemcitabine
hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and
erlotinib hydrochloride.

- Determine the safety and toxicity of this regimen in these patients.


- Evaluate the objective response rate in these patients.

- Evaluate time to tumor progression in these patients.

- Determine the efficacy of this regimen, in terms of the proportion of patients with ≥
50% decline in CA19-9 biomarker, in these patients.

- Obtain sequential measurements of circulating tumor cells (micrometastases) and
endothelial cells in serum and correlate these variables with clinical outcomes (in
patients enrolled in UCSF site only).

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride
once daily on days 1-21. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.

Patients undergo blood collection at baseline and periodically during study for
biomarker/laboratory analysis, including the CA19-9 biomarker. Circulating tumor
micrometastases and endothelial cells are also measured in patients enrolled in UCSF site.

After completion of study treatment, patients are followed at 30 days and at 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Documented extrapancreatic metastases

- Radiographically measurable disease not required

- Gemcitabine hydrochloride-refractory disease

- Has undergone 1-3 prior therapies for locally advanced or metastatic disease
with ≥ 1 regimen containing gemcitabine hydrochloride (alone or in combination
with other agents)

- Treatment given in the adjuvant setting (radiotherapy and/or chemotherapy,
given either concurrently or systemically) does not count as prior therapy
as long as progressive disease occurs > 6 months after completion of

- No CNS or brain metastases


- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- INR ≤ 1.5 (except in patients receiving full-dose warfarin)

- Bilirubin ≤ 2.0 mg/dL

- Creatinine ≤ 2.0 mg/dL

- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if documented liver

- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)

- No contact lense use during and for 14 days after completion of study treatment

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- No history of other disease, metabolic dysfunction, or physical examination or
clinical laboratory finding that contraindicates use of an investigational drug or
precludes study compliance

- No history of serious systemic disease, including any of the following:

- Myocardial infarction within the past 6 months

- Stroke within the past 6 months

- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- Unstable symptomatic arrhythmia requiring medication

- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia) allowed

- Peripheral vascular disease ≥ grade 2

- No significant traumatic injury within the past 28 days

- No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 at screening)

- No clinically significant impairment of renal function

- No serious, nonhealing wound, ulcer, or bone fracture

- No evidence of bleeding diathesis or coagulopathy

- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months


- More than 28 days since prior major surgery or open biopsy

- More than 7 days since prior fine-needle aspiration or core biopsy

- No prior antiangiogenesis agent (e.g., bevacizumab or an oral vascular endothelial
growth factor receptor small molecule inhibitor) given together with an agent that
disrupts epidermal growth factor receptor signaling (e.g., cetuximab or erlotinib
hydrochloride) for locally advanced or metastatic pancreatic cancer

- Prior treatment with either one of the above alone allowed

- More than 4 weeks since prior and no concurrent participation in another clinical

- No other concurrent antineoplastic or antitumor agents, including chemotherapy,
radiotherapy, immunotherapy, or hormonal anticancer therapy

- No concurrent major surgery

- No other concurrent investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival rate at 6 months

Safety Issue:


Principal Investigator

Andrew Ko, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

March 2010

Related Keywords:

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



UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115