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About
This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Full description
PRIMARY OBJECTIVES:
l. To assess overall survival (as measured by median survival and proportion of patients alive at 24 weeks) in patients with advanced pancreatic cancer who have received one prior line of systemic therapy when treated with the combination of AZD6244 (selumetinib) and erlotinib (erlotinib hydrochloride).
SECONDARY OBJECTIVES:
I. Progression-free survival (median progression-free survival [PFS] and proportion of patients with PFS at 12 and 24 weeks).
II. Cancer antigen (CA)19-9 biomarker response (defined as a 50% decline in serum CA19-9 level from baseline in patients with > 2 x upper limit of normal [ULN] CA19-9 measurement).
III. Objective radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
IV. Safety and toxicity profile of the combination of AZ6244 and erlotinib.
OUTLINE:
Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2-3 months.
Enrollment
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Inclusion criteria
Histologically or cytologically proven adenocarcinoma of the pancreas
Patients must have locally advanced unresectable disease not amenable to curative resection or extrapancreatic metastases; patients must have EITHER radiographically measurable disease (defined as at least one lesion that can be accurately measured in at least one dimension [longest diameter to be recorded] as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography [CT] scan) AND/OR a serum CA19-9 measurement > 2 x ULN
One prior line of systemic therapy for advanced disease (locally advanced or metastatic)
The following represent acceptable examples meeting the definition of one prior line of therapy:
For patients with locally advanced disease, prior radiation to the primary tumor is allowable as long as there is clear evidence of disease progression (either radiographic locoregional disease progression and/or a rising CA19-9 level); patients may have received chemotherapy both concurrently and/or sequentially with (either before or after) the radiation and still be eligible for the study, as this would be considered all part of the same course of treatment
Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or sequentially) does not count as prior therapy as long as progressive disease occurs > 6 months following completion of treatment
Life expectancy of greater than 8 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) >= 1500/uL
Platelet count >= 100,000/uL
International normalized ratio (INR) =< 1.5 (except those subjects who are receiving full-dose warfarin)
Total bilirubin =< 2.0 mg/dL
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 times the upper limit of normal for subjects
Serum creatinine of =< 2.0 mg/dL
Pregnancy test for women of childbearing potential (serum or urine beta-human chorionic gonadotropin [HCG])
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases; women of child-bearing potential must have a negative pregnancy test prior to entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle
Ability to understand and the willingness to sign a written informed consent document
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46 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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