Clinical Trial VICCGI1173
Title
A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients with Advanced Pancreatic Carcinoma
Principal Investigator(s)
Details
- Protocol No. VICCGI1173
- Open Date: 07/31/2012
- Staging: Phase I
- Age Group: Adults
- Scope: Local
- Objective: To determine the maximum tolerated dose (also Phase II recommended dose) of the combination of gemcitabine, erlotinib and dasatinib in patients with advanced pancreatic adenocarcinoma.
- Disease Sites: Gastrointestinal; Phase I; Pancreatic
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Dasatinib (BMS-354825); Gemcitabine; Tarceva (OSI-774; erlotinib)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01660971
- Secondary Protocol No: NCI Protocol # 9043
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• 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 glutamic 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
Exclusion Criteria:
• 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 because of the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib or dasatinib, breastfeeding should be discontinued if the mother is treated with erlotinib or dasatinib
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy and are thus excluded
• Patients on potent cytochrome P450 3A4 (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
• Myocardial infarction or ventricular tachyarrhythmia within 6 months
• Prolonged corrected QT interval (QTc) > 480 msec (Fridericia correction)
• Known ejection faction less than institutional normal
• Major conduction abnormality (unless a cardiac pacemaker is present)
Learn More
- Call toll-free number: 1-800-811-8480
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