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Phase III Randomized Study of Gemcitabine With or Without Erlotinib in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Closed | 18 and over | CAN-NCIC-PA3 OSI-CAN-NCIC-PA3, NCT00026338, PA3 |
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.
Entry Criteria Disease Characteristics:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or metastatic disease that is considered unresectable
- No known CNS metastases
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: 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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment A total of 800 patients (400 per treatment arm) will be accrued for this study
within 11 months. 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. Published ResultsMoore 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. Moore MJ, Goldstein D, Hamm J, et al.: 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 25 (15): 1960-6, 2007.[PUBMED Abstract] 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. Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. [Abstract] J Clin Oncol 23 (Suppl 16): A-1, 1s, 2005.
Trial Contact Information
Trial Lead Organizations NCIC-Clinical Trials Group | | | Malcolm Moore, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer | | Trial Start Date | | 2001-08-10 | | Registered in ClinicalTrials.gov | | NCT00026338 | | Date Submitted to PDQ | | 2001-09-24 | | Information Last Verified | | 2003-15-03 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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