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Study identifier: NCT00026338 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Pancreatic Cancer  ·  Sponsor: NCIC Clinical Trials Group

PhasePhase 3
Planned participants569
Who can joinAll sexes, 18 Years to 120 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where173 locations · 19 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (173)

Arizona Clinical Research CenterTucson, Arizona, United States
Highlands Oncology GroupSpringdale, Arkansas, United States
Alta Bates Comprehensive Cancer CenterBerkeley, California, United States
Sutter Health West Cancer Research GroupGreenbrae, California, United States
Loma Linda University Cancer InstituteLoma Linda, California, United States
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California, United States
Kenmar Research InstituteLos Angeles, California, United States
Century City HospitalLos Angeles, California, United States
David Geffen School of MedicineLos Angeles, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California, United States
Davis, Posteraro, & Wasser, MDs, LLPManchester, Connecticut, United States
New Britain General HospitalNew Britain, Connecticut, United States

+ 161 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

TucsonSpringdaleBerkeleyGreenbrae

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