A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: CABOZANTINIB; gemcitabine
Intervention description: Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice.; Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.
Intervention MeSH terms: Gemcitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oncology; pancrease

Summary:

      Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is
      approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated
      effectiveness against pancreatic cancer in laboratory experiments, especially when given with
      gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity
      against the disease. The purpose of this study is to determine the safest and highest dose of
      cabozantinib that can be given together with standard doses of gemcitabine in patients with
      pancreatic cancer. This study will determine the safety and tolerability of this two drug
      combination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. pathologically confirmed pancreatic carcinoma.

          2. locally advanced unresectable disease, metastatic disease, or recurrent disease
             following surgical therapy.

          3. ≥ 18 years old.

          4. Life expectancy of greater than 12 weeks.

          5. ECOG performance status ≤1 (Karnofsky ≥70%) (See Appendix A).

          6. adequate organ and marrow function as follows:

          7. capable of understanding and complying with the protocol requirements and has signed
             the informed consent document.

          8. use medically accepted barrier methods of contraception

          9. women of childbearing potential must have a negative pregnancy test at screening.

        Exclusion Criteria:

          1. neuroendocrine tumors of the pancreas.

          2. more than 1 prior systemic treatment regimen for pancreatic cancer. may have received
             prior neoadjuvant or adjuvant therapy, including gemcitabine, provided 6 months have
             elapsed from completion of that treatment and the start of study therapy.

          3. Previous gemcitabine therapy for advanced pancreatic cancer. Patients who have had
             chemotherapy within 4 weeks, nitrosoureas/mitomycin C within 6 weeks, or monoclonal
             antibody within 6 weeks prior to planned initiation of study treatment.

          4. prior treatment with a small molecule kinase inhibitor or a hormonal therapy within 14
             days or five half-lives of the compound or active metabolites, whichever is longer,
             before the first dose of study treatment.

          5. have received an investigational agent within 28 days of the first dose of study
             treatment or 5 half-lives of the compound or active metabolite, whichever is longer.

          6. have received radiation therapy within 14 days of study treatment.

          7. have not recovered from toxicity due to all prior therapies (i.e., return to
             pretherapy baseline or to CTCAE Grade 0 or 1) except alopecia and non-clinically
             significant AEs.

          8. known brain metastases.