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A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Pancreas Cancer

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Trial Information

A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers

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: 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

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.

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-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 chemotherapy and radiation is allowed as defined above.

- 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 institution's normal range and INR (International Normalized Ratio) < 1.5.

- Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant

- 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 parameters as outlined in the
protocol 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 not willing to use contraception

- Patients with brain metastases or any history of brain metastases

- Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal, or
intra-pelvic) from side effects of 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 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

- Concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate are
not permitted

- Concurrent use of other investigational drugs is not permitted.

- The administration of other antineoplastic therapy is not permitted

- Anticipated patient survival under 4 months for maintenance cohorts and 6 months for

- Patients with any of the following concurrent severe and/or uncontrolled medical
conditions which could compromise participation in the study. Impaired cardiac
function or clinically significant cardiac diseases, including any of the following:

1. History or presence of serious uncontrolled ventricular arrhythmias

2. Clinically significant resting bradycardia

3. LVEF assessed by 2-D echocardiogram < 50% or lower limit of normal (whichever is
higher) or multiple gated acquisition scan < 45% or lower limit of normal
(whichever is higher)

4. Any of the following within 6 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary artery bypass graft,
congestive heart failure, cerebrovascular accident, transient ischemic attack

5. Uncontrolled hypertension defined by a SBP >/= 160 mm Hg and/or DBP >/= 100 mm
Hg, with or without anti-hypertensive medication. Initiation or adjustment of
antihypertensive medication(s) is allowed prior to study entry.

- Life-threatening visceral disease or other severe concurrent disease

- Patients receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to dovitinib.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biomarker discovery

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John L Marshall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

August 2016

Related Keywords:

  • Colorectal Cancer
  • Pancreas Cancer
  • Maintenance therapy
  • Adjuvant Therapy
  • Colorectal Neoplasms
  • Pancreatic Neoplasms



Georgetown University- Lombardi Cancer Center Washington, District of Columbia  20007