Maintenance Dovitinib for Colorectal and Pancreas Cancer

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Novartis
• Treatments: Pancrelipase

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 beinstitution'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)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 antibodiesprior 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.