Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery

Running, not enrolling · Phase 1

Conditions studied: Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7

In brief

This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and dasatinib together with erlotinib hydrochloride may kill more tumor cells.

Key facts

Study ID: NCT01660971
Run by: National Cancer Institute (NCI)
People needed: 19
Starts: 2012-07-30
Expected to finish: 2027-03-31
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be > 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
Patients may have received prior radiation presuming > 4 weeks since last dose and measurable disease outside the radiation field
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Anticipated life expectancy of greater than 3 months
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin < 2.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic pyruvate transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal OR =< 5 x institutional upper limit of normal when liver metastases are present
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
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 and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Patients must be able to swallow pills

You may not qualify if…

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (with the exception of alopecia and neuropathy); no radiation is allowed on study
Patients who are receiving any other investigational agents
Major surgical procedure within 4 weeks of treatment
Patients with known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, erlotinib or gemcitabine
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with erlotinib or dasatinib
Patients with immune deficiency are excluded
Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
Malabsorption syndrome or other condition that would interfere with intestinal absorption
Other active malignancy (with the exception of locally treated non-melanoma skin cancers)
Human immunodeficiency virus (HIV) positive patients who are on combination antiretroviral therapy
Patients may not have any clinically significant cardiovascular disease including the following:
Myocardial infarction or ventricular tachyarrhythmia within 6 months
Prolonged corrected QT (QTc) > 480 msec (Fridericia correction)
Known ejection faction less than institutional normal
Major conduction abnormality (unless a cardiac pacemaker is present)

Where it is running

Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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