Know Cancer

or
forgot password

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
N/A
Not Enrolling
Both
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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Malcolm J. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

PA3

NCT ID:

NCT00026338

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Beth Israel Medical CenterNew York, New York  10003
University Hospitals of ClevelandCleveland, Ohio  44106
Green Mountain Oncology GroupRutland, Vermont  05701
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
St. Barnabas Medical CenterLivingston, New Jersey  07039
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Baystate Medical CenterSpringfield, Massachusetts  01199
Staten Island University HospitalStaten Island, New York  10305
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Mountain States Tumor InstituteBoise, Idaho  83712
Tuft-New England Medical CenterBoston, Massachusetts  02111
Cooper Cancer InstituteCamden, New Jersey  08103
Southwest Regional Cancer CenterAustin, Texas  78705
Sutter Health West Cancer Research GroupGreenbrae, California  94904
New Britain General HospitalNew Britain, Connecticut  06050
Interlakes Oncology/Hematology PCRochester, New York  14623
Arlington Cancer CenterArlington, Texas  76012
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Ocala Oncology CenterOcala, Florida  34474
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967
Florida Cancer SpecialistsFort Myers, Florida  33901
Northwest Medical Specialists, P.C.Arlington Heights, Illinois  60004
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Midwest Cancer Research Group, Inc.Skokie, Illinois  60077
Carle Cancer CenterUrbana, Illinois  61801
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Tulane Cancer CenterNew Orleans, Louisiana  70112
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Arena Oncology AssociatesGreat Neck, New York  11021
Midwest Oncology ConsortiumKansas City, Missouri  64111
St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997
Norton Healthcare PavilionLouisville, Kentucky  40202
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Arizona Clinical Research CenterTucson, Arizona  85712
Loma Linda University Cancer InstituteLoma Linda, California  92354
Highlands Oncology GroupSpringdale, Arkansas  72764
Hematology Oncology, P.C.Stamford, Connecticut  06902
Berkshire Physicians and Surgeons, P.C.Pittsfield, Massachusetts  01201
University Hospital - Stony BrookStony Brook, New York  11794-8174
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Texas Cancer CareFort Worth, Texas  76104
Hematology & Oncology Associates of VirginiaRichmond, Virginia  23226
Charleston Hematology-Oncology, P.A.Charleston, South Carolina  29403
Central Georgia Hematology Oncology, P.C.Macon, Georgia  31201
Oncology & Hematology Associates of West BrowardTamarac, Florida  33321
Kenmar Research InstituteLos Angeles, California  90057
Southwest Washington Medical CenterVancouver, Washington  98664
David Geffen School of MedicineLos Angeles, California  90095-7059
Century City HospitalLos Angeles, California  90067
Davis, Posteraro, & Wasser, MDs, LLPManchester, Connecticut  06040
Moffitt Clinic at Tampa General HospitalTampa, Florida  33612-9497
Medical ConsultantsMuncie, Indiana  47304
Metairie, Louisiana  70006
Annapolis Medical SpecialistsAnnapolis, Maryland  21401
New Hampshire Oncology-Hematology PAHooksett, New Hampshire  03106
Hematology-Oncology AssociatesMount Holly, New Jersey  08060
Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Hematology-Oncology Association of NE PennsylvaniaDunmore, Pennsylvania  18512
Tyler Hematology Oncology, P.A.Tyler, Texas  75701
Western Washington OncologyOlympia, Washington  98502
Oncology of WisconsinGlendale, Wisconsin  53212