Maintenance Dovitinib for Colorectal and Pancreas Cancer
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|ClinicalTrials.gov Identifier: NCT01888965|
Recruitment Status : Terminated (Adverse Event issues.)
First Posted : June 28, 2013
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Pancreas Cancer||Drug: Dovitinib||Phase 2|
This is a single institution, nonrandomized, open-label pilot study of dovitinib as maintenance and adjuvant therapy in patients with colorectal and pancreas cancers.
Cohort 1: Stage 4 Colon Cancer s/p metastasectomy (Adjuvant cohort)
Cohort 2: Stage 4 Colon Cancer after initial chemotherapy (Maintenance cohort)
Cohort 3: Pancreas Cancer s/p resection and adjuvant chemo (Adjuvant cohort)
Cohort 4: Locally advanced pancreas cancer s/p chemo and radiation (Maintenance cohort)
Each of the 4 cohorts will be accrued independently. 15 patients will be accrued to each cohort. Treatment will begin following the completion of the standard adjuvant or induction therapy. Patients will continue to take dovitinib until they demonstrate progression of disease using standard RECIST criteria, withdraw consent, or experience unacceptable toxicity.
Blood and urine Biomarker studies will be performed on all patients in all cohorts. Samples will be collected at baseline and every 8 weeks for the first 6 months and then every 3 months thereafter, while patients are on study. Blood and urine will be collected and banked for protein, miRNA and metabolomic analysis. Tumor specimens will be taken from patients in maintenance cohorts before and 2 weeks after initiation of dovitinib. All of these samples will be analyzed to determine if biomarkers of benefit and progression can be determined.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||October 2014|
Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
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
Other Name: TKI258
- Biomarker Discovery [ Time Frame: 2 years ]Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum
- Progression-free Survival [ Time Frame: 2 years ]
Time in days from study entry until disease progression or death
Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions
- Safety [ Time Frame: 2 years ]Percent of subjects who experience grade 3/ 4 adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888965
|United States, District of Columbia|
|Georgetown University- Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||John L Marshall, MD||Georgetown University|