Status:
TERMINATED
Maintenance Dovitinib for Colorectal and Pancreas Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Novartis
Conditions:
Colorectal Cancer
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a single institution, nonrandomized, open-label pilot study of dovitinib as maintenance and adjuvant therapy in patients with colorectal and pancreas cancers. Patient Populations: Cohort 1: ...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of:
- 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.
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01888965
Start Date
October 1 2013
End Date
October 1 2014
Last Update
July 19 2016
Active Locations (1)
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1
Georgetown University- Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007