Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

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Brief Title

Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Official Title

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

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Biological therapies such as erlotinib use different ways to
      stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and
      biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more
      effective with or without erlotinib in treating pancreatic cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and
      without erlotinib in treating patients who have unresectable locally advanced or metastatic
      pancreatic cancer.
    

Detailed Description

      OBJECTIVES:

        -  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 regimens.

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

        -  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
           daily.

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

      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival

Secondary Outcome

 Progression free survival

Condition

Pancreatic Cancer

Intervention

erlotinib hydrochloride

Study Arms / Comparison Groups

 OSI-774 plus Gemcitabine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

569

Start Date

August 2001

Completion Date

February 2009

Primary Completion Date

September 2004

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  Locally advanced or metastatic disease that is considered unresectable

          -  No known CNS metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

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

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

        Hepatic:

          -  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)

        Renal:

          -  Creatinine less than 1.5 times ULN

        Cardiovascular:

          -  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

        Gastrointestinal:

          -  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

        Ophthalmic:

          -  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
                  keratitis)

        Other:

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent biologic therapy or immunotherapy

        Chemotherapy:

          -  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

        Radiotherapy:

          -  See Chemotherapy

          -  At least 4 weeks since prior radiotherapy and recovered

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

          -  No concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  At least 2 weeks since prior major surgery

          -  No concurrent ophthalmic surgery

        Other:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Malcolm J. Moore, MD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00026338

Organization ID

PA3

Secondary IDs

CAN-NCIC-PA3

Responsible Party

Sponsor

Study Sponsor

NCIC Clinical Trials Group


Study Sponsor

Malcolm J. Moore, MD, Study Chair, Princess Margaret Hospital, Canada


Verification Date

September 2011