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Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib
hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2,
downstream signaling molecules, and other molecular markers by immunohistochemistry and
RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR,
HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and
periodically during study for polymorphism analysis and correlative molecular analysis of
surrogate endpoint biomarkers.

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

Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced, metastatic or recurrent
pancreatic carcinoma

- Must have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension

- No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant
chemotherapy is allowed provided that patients did not receive gemcitabine and the
chemotherapy was completed > six months prior to initiation of study therapy. Prior
erlotinib therapy is not allowed

- Available tumor specimen that was obtained at the time of diagnosis and/or prior to
study entry is highly encouraged

- Age ≥ 18 years

- Life expectancy greater than 3 months

- Zubrod performance status ≤ 2

- Patients must have normal organ and marrow function as defined below:

- leukocytes ≥ 3,000/μL

- absolute neutrophil count ≥ 1,500/ μL

- platelets ≥ 100,000/ μL

- total bilirubin ≤ 1.5 X institutional upper limit of normal

- AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the
liver is involved with tumor, in which case the AST/ALT must be ≤ 5 X
institutional upper limit of normal

- creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR

- creatinine ≤ 1.5 X institutional upper limit of normal

- The effects of erlotinib and gemcitabine on the developing human fetus at the
recommended therapeutic doses are unknown. Women of child-bearing potential and men
must agree to use adequate contraception prior to study entry and for the duration
of study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents.

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to erlotinib or gemcitabine.

- Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that
would limit compliance with study requirements.

- Pregnant women are excluded from this study because erlotinib and gemcitabine have
the potential for teratogenic or abortifacient effects. Breastfeeding should be
discontinued if the mother is treated with study drugs.

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy.

Type of Study:


Study Design:

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

Outcome Measure:

Response rate (partial response or complete response) and duration of response

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Primo N. Lara, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817