Maintenance Dovitinib for Colorectal and Pancreas Cancer

This is an interventional treatment trial for Colorectal Cancer focused on measuring Maintenance therapy, Adjuvant Therapy Read More

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.