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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
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Georgetown University

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 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

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: 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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dovitinib
Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Drug: Dovitinib

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. Safety [ Time Frame: 2 years ]
    Percent of subjects who experience grade 3/ 4 adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

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


Locations
United States, District of Columbia
Georgetown University- Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Novartis
Investigators
Principal Investigator: John L Marshall, MD Georgetown University

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01888965     History of Changes
Other Study ID Numbers: CTK1258AUS16T
Pro063 ( Other Identifier: Georgetown University )
First Posted: June 28, 2013    Key Record Dates
Results First Posted: July 19, 2016
Last Update Posted: July 19, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Georgetown University:
Maintenance therapy
Adjuvant Therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents