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Phase II Study of 5-Fluorouracil, Oxaliplatin Plus Dasatinib (FOLFOX-D) in First-line Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer Metastatic

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Trial Information

Phase II Study of 5-Fluorouracil, Oxaliplatin Plus Dasatinib (FOLFOX-D) in First-line Metastatic Pancreatic Adenocarcinoma

Systemic control of pancreatic cancer remains a clinical unmet need. The recent superiority
of 5-FU based combination therapies over the historical standard gemcitabine represents an
opportunity to develop novel combinations of synergistic and effective cytotoxic and
biologic targeted therapies. Src excess activity has been demonstrated in pancreatic cancer
and is implicated in the invasive and metastatic phenotype clearly represented by this
disease. Inhibition of Src activity is associated with numerous biologic modifications
capable of positively modifying this phenotype and appears to have synergy with restoring
inherent chemosensitivity. The addition of dasatinib to FOLFOX (FOLFOX-D) represents a novel
therapeutic regimen in pancreatic cancer with safety and pharmacokinetic data already having
been established in colorectal cancer. This protocol will test the safety and activity of
this combination in pancreatic cancer where current clinical outcomes remain far from

Inclusion Criteria:

- Pancreatic adenocarcinoma with evidence of metastatic disease on imaging

- Measurable disease (per RECIST 1.1)

- ECOG Performance Status 0-2

- No prior chemotherapy or radiotherapy for metastatic pancreatic cancer. Patients may
have received prior treatment for non-metastatic disease; however the diagnosis of
metastatic disease must have been made more than 6 months after completion of

- Patients may have a history of other malignancies if there is no current evidence of
persistent or recurrent disease and they are not undergoing any active therapy
(including hormonal)

- Patent biliary system

- Patients receiving anti-coagulation treatment with an agent such as Coumadin or
heparin may be allowed to participate, provided they are on stable anti-coagulation
therapy with no active bleeding and have no condition that carries a high risk of

- Adequate organ and marrow function

- Ability to take oral medication (dasatinib must be swallowed whole)

- Patient agrees to discontinue prohibited concomitant medications

- Age > 18 years

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception throughout the study and for at least 4 weeks after the last dose of
study drug.

- A male subject of fathering potential must use an adequate method of contraception
throughout the study and for at least 4 weeks after the last dose of study drug.

Exclusion Criteria:

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for at least 4 weeks after the last dose of study drug.
Women who are pregnant or breastfeeding and sexually active fertile men not using
effective birth control if their partners are WOCBP are also excluded.

- History of known brain metastases or carcinomatous meningitis

- Recent major surgery (within 4 weeks) or minor surgery (within 2 weeks), excluding
placement of a vascular access device or biliary stent

- Uncontrolled diabetes

- Any sensory neuropathy > grade 1 at baseline

- Serious active or uncontrolled infection

- Concurrent medical condition which may increase the risk of toxicity including
clinically significant pleural or pericardial effusion, patients with known DPD
deficiency or patients with a history of allergic reactions attributed to
oxaliplatin, 5-FU or leucovorin.

- Cardiac Symptoms including unstable angina or stable angina markedly limiting
ordinary physical activity, NYHA class III or IV congestive heart failure, myocardial
infarction or stroke within 6 months of study enrollment, diagnosed congenital long
QT syndrome, any history of clinically significant ventricular arrhythmias, prolonged
QTc interval on pre-entry ECG or clinically significant peripheral vascular disease.

- Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to
dasatinib administration

- History of significant bleeding disorder unrelated to cancer, including diagnosed
congenital bleeding disorders, diagnosed acquired bleeding disorder within one year
or ongoing or recent (≤ 3 months) significant gastrointestinal bleeding.

- History of any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of protocol therapy, might affect the interpretation of
the results of the study, or that puts the subject at high risk for treatment

- Use of category I drugs that are generally accepted to have a risk of causing
Torsades de Pointes

- Use of potent CYP3A4 inhibitors that significantly increase dasatinib exposure

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness

- Inability to comply with study and/or follow-up procedures

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dasatinib activity

Outcome Description:

Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Thomas J George, Jr., MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

July 2017

Related Keywords:

  • Pancreatic Cancer Metastatic
  • Metastatic
  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary



University of Florida Shands Cancer Center Gainesville, Florida  32610-0232