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Clinical Trial VICCGI1173

Title

A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients with Advanced Pancreatic Carcinoma

Principal Investigator(s)

Dana Cardin

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 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
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, 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
• 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)