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NCT00026338 · CITED IN SOURCE DOCUMENTS

Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-04-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: erlotinib hydrochloride
    2. Drug: gemcitabine hydrochloride
    label
    OSI-774 plus Gemcitabine
    type
    ACTIVE_COMPARATOR
  2. intervention Names
    1. Drug: gemcitabine hydrochloride
    label
    Placebo plus gemcitabine
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. OSI-774 plus Gemcitabine
    description
    150 mg po daily
    name
    erlotinib hydrochloride
    type
    DRUG
  2. arm Group Labels
    1. OSI-774 plus Gemcitabine
    2. Placebo plus gemcitabine
    description
    1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)
    name
    gemcitabine hydrochloride
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
569
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    3 years
secondary Outcomes
  1. measure
    Progression free survival
    time Frame
    3 years
  2. description
    Canada, US and selected countries only
    measure
    Quality of Life
    time Frame
    3 years
  3. description
    Complete and partial response only.
    measure
    Response rates
    time Frame
    3 years
  4. measure
    Toxicity
    time Frame
    3 years
  5. description
    Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
    measure
    EGFR levels
    time Frame
    3 years
  6. description
    To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
    measure
    Pharmacokinetics
    time Frame
    3 years
Full study description
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.
Source references
references
  1. citation
    Dhani NC, Tu D, Parulekar W, et al.: A retrospective analysis of tumor size (TS) as a continuous rather than discrete variable in advanced pancreatic cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-e15565, 2009.
    type
    BACKGROUND
  2. citation
    Moore MJ, da Cunha Santos G, Kamel-Reid S, et al.: The relationship of K-ras mutations and EGFR gene copy number to outcome in patients treated with Erlotinib on National Cancer Institute of Canada Clinical Trials Group trial study PA.3. [Abstract] J Clin Oncol 25 (Suppl 18): A-4521, 2007.
    type
    RESULT
  3. citation
    Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. doi: 10.1200/JCO.2006.07.9525. Epub 2007 Apr 23.
    pmid
    17452677
    type
    RESULT
  4. citation
    Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib improves survival when added to gemcitabine in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-77, 2005.
    type
    RESULT
Source notices and limitations
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        /div></li><li>Gemcitabine alone versus gemcitabine and erlotinib: The National Cancer Institute of Canada performed a phase III trial (<a href="/clinicaltrials/NCT00026338">CAN-NCIC-PA3</a> [NCT00026338]) that compared gemcitabine alone with the combination of gemcitabine and erlotinib (100 mg/d) in patients with advanced or meta
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        versus gemcitabine and erlotinib: The National Cancer Institute of Canada performed a phase III trial (<a href="/clinicaltrials/NCT00026338">CAN-NCIC-PA3</a> [NCT00026338]) that compared gemcitabine alone with the combination of gemcitabine and erlotinib (100 mg/d) in patients with advanced or metastatic pancreatic carcinomas.[<
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      1. context
        Updated: February 12, 2025
        datetime
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice