Condition: Pancreatic Cancer · Sponsor: NCIC Clinical Trials Group
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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.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
| Arizona Clinical Research Center | Tucson, Arizona, United States | — |
| Highlands Oncology Group | Springdale, Arkansas, United States | — |
| Alta Bates Comprehensive Cancer Center | Berkeley, California, United States | — |
| Sutter Health West Cancer Research Group | Greenbrae, California, United States | — |
| Loma Linda University Cancer Institute | Loma Linda, California, United States | — |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, United States | — |
| Kenmar Research Institute | Los Angeles, California, United States | — |
| Century City Hospital | Los Angeles, California, United States | — |
| David Geffen School of Medicine | Los Angeles, California, United States | — |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California, United States | — |
| Davis, Posteraro, & Wasser, MDs, LLP | Manchester, Connecticut, United States | — |
| New Britain General Hospital | New Britain, Connecticut, United States | — |
+ 161 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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