Maintenance Dovitinib for Colorectal and Pancreas Cancer
Condition: Colorectal Cancer; Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Dovitinib
Intervention description: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
If 500 mg is intolerable, 400 mg will be dosed. If 400 mg is intolerable, 300 mg will be dosed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Maintenance therapy; Adjuvant Therapy

Summary:

      This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had
      surgery to remove metastases and patients with pancreas cancer, which has been surgically
      removed and are receiving adjuvant chemotherapy or is locally advanced and have already
      received chemotherapy and radiation.

      The purpose of this study is to determine the effects of oral dovitinib in patients with
      advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free
      survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to
      2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a confirmed diagnosis of:

               1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or
                  maintenance "standard of care", either involving 5-fluorouracil/leucovorin
                  (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort
                  must have had 2 consecutive CT scans showing stable disease and not be
                  experiencing significant prior treatment-related toxicity above Grade 1.

               2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally
                  advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or
                  radiation therapy may have been stopped between 2 weeks and 2 months prior to
                  study start, and patients must have recovered from prior treatment related
                  toxicity to grade 1 or less.

          -  Prior surgery, including tumor resection or metastasectomy must have been performed at
             least 4 weeks prior to study enrollment.

          -  No concomitant anti-cancer treatment is allowed

          -  Age >/= 18 years

          -  Performance status of 0-1

          -  Adequate hepatic, bone marrow, and renal function

          -  Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of
             institution's normal range and INR (International Normalized Ratio) < 1.5.

          -  Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant
             cohorts

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days prior to initiation of treatment and must not be lactating.

          -  Subject is capable of understanding and complying with protocol demands and able to
             sign and date the informed consent

        Exclusion Criteria:

          -  Women of child-bearing potential, who are biologically able to conceive, not employing
             two forms of highly effective contraception or who are pregnant.

          -  Women who are breast-feeding

          -  Fertile males unwilling to use contraception

          -  Patients with brain metastases or any history of brain metastases

          -  Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or
             -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from
             such therapy

          -  Patients with a history of pulmonary embolism, or untreated deep vein thrombosis
             within the past 6 months

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of dovitinib

          -  The subject has had another active malignancy within the past 5 years except for
             cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of
             the skin.

          -  Patients who have received the last administration of an anticancer therapy including
             chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks
             prior to starting the study drug, or who have not recovered from the side effects of
             such therapy

          -  Cirrhosis, chronic active hepatitis or chronic persistent hepatitis

          -  Patients who are currently receiving prasugrel

          -  No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate

          -  No concurrent use of other investigational drugs or antineoplastic therapies.

          -  Patients with impaired cardiac function or clinically significant cardiac diseases.