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A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer


- Compare the overall survival rate in patients with unresectable locally advanced or
metastatic pancreatic cancer treated with gemcitabine with or without erlotinib.

- Compare the progression-free survival rate in patients treated with these regimens.

- Compare the quality of life of patients treated with these regimens.

- Compare the response rate and response duration in patients treated with these

- Compare the nature, severity, and frequency of toxic effects of these regimens in these

- Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis
with outcome and response in patients treated with these regimens.

- Determine the pharmacokinetics of erlotinib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, extent of disease (locally advanced vs
metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36,
and 43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all
subsequent courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral
erlotinib once daily.

- Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once

Treatment continues in both arms in the absence of disease progression or unacceptable

Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent
courses, at 4 weeks after study, and then every 12 weeks until disease progression.

Patients are followed at 4 weeks and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
study within 11 months.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Locally advanced or metastatic disease that is considered unresectable

- No known CNS metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin less than 2 times upper limit of normal (ULN)

- AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)


- Creatinine less than 1.5 times ULN


- No uncontrolled high blood pressure

- No unstable angina

- No congestive heart failure

- No myocardial infarction within the past year

- No cardiac ventricular arrhythmias requiring medication


- No gastrointestinal (GI) tract disease resulting in an inability to take oral
medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or
ulcerative colitis)

- No post-surgical malabsorption characterized by:

- Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR

- Requires IV hyperalimentation

- Pancreatic enzyme supplementation allowed provided that the above criteria are
not met


- No ocular inflammation or infection unless fully treated prior to study

- No significant ophthalmologic abnormalities, including the following:

- Severe dry eye syndrome

- Sjogren's syndrome

- Keratoconjunctivitis sicca

- Severe exposure keratopathy

- Disorders that would increase the risk for epithelium-related complications
(e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No serious active infection

- No other serious underlying medical, psychological, or geographical condition that
would preclude study participation

- No prior allergic reaction to compounds with similar chemical or biologic composition
to erlotinib

- No other prior malignancy within the past 5 years except cancer in situ or basal cell
or squamous cell skin cancer


Biologic therapy:

- No concurrent biologic therapy or immunotherapy


- No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or
gemcitabine administered concurrently with radiotherapy as a radiosensitizer

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- Not specified


- See Chemotherapy

- At least 4 weeks since prior radiotherapy and recovered

- Prior radiotherapy for local disease allowed if evidence of disease progression has

- No concurrent radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior major surgery

- No concurrent ophthalmic surgery


- No prior epidermal growth factor receptor inhibitors

- At least 2 weeks since prior investigational drug

- No other concurrent investigational drugs during and for at least 30 days after study

- No other concurrent anti-cancer therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Malcolm J. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

August 2001

Completion Date:

February 2009

Related Keywords:

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



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