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Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02023333
Recruitment Status : Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : November 1, 2022
Sponsor:
Collaborators:
Bayer
State University of New York - Downstate Medical Center
Queens Cancer Center of Queens Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to evaluate the good and bad effects when regorafenib is used instead of standard combination chemotherapy. It is not known if taking regorafenib versus standard chemotherapy will have better, worse or the same results.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Adenocarcinoma Drug: Regorafenib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma
Study Start Date : December 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Regorafenib
This is an open-label, phase II study of regorafenib for patients with metastatic colorectal carcinoma. The treatment will be repeated every week for three weeks on and one week off. Patients will be evaluated for response after every 2 cycles (8 weeks).
Drug: Regorafenib
All patients that meet the eligibility criteria who have signed informed consent and have enrolled on the trial will be treated with regorafenib, daily 3 weeks on 1 week off for all cycles. Dose will be escalated to 120 mg in week 2 of cycle 1 and all remaining cycles if no excess toxicity is experienced by the patient at the discretion of the treating physician.
Other Name: BAY 73-45060




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 16 weeks ]
    Response and progression will be evaluated in this study using the international criteria proposed by the RECIST 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
    Overall survival is defined as the time from treatment start to death or last follow up. Survival will be estimated using the Kaplan-Meier method.

  2. disease control rate [ Time Frame: 16 weeks ]
    Disease control rate (defined with RECIST 1.1 criteria at 16 weeks (2nd scan) as CR, PR or SD), will be estimated using proportions and exact binomial 95% confidence intervals provided.

  3. duration of stable disease [ Time Frame: 2 years ]
    Duration of stable disease will be defined as the time from stable disease to the time of documented progression.

  4. toxicity [ Time Frame: 2 years ]
    will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0. The assessments will be based on recorded adverse events, physical examinations, and clinical laboratory assessments. Toxicity will be summarized using descriptive statistics.



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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:

  • Age ≥ 18 years.
  • Life expectancy of at least 12 weeks (3 months).
  • Untreated for metastatic colorectal cancer, or progression on any first line 5-FU containing regimen (such as FOLFOX or FOLFIRI)
  • Histologically proven colorectal adenocarcinoma

    • Metastatic disease, unresectable disease involving one or more sites including liver, lung, lymph nodes and peritoneum, with each nodule measuring ≤3cm OR no more than two sites of disease (two nodules) >4.5 cm.
  • ECOG 0 or 1
  • Adequate bone marrow, liver and liver function as assessed by the following laboratory requirements:
  • Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 xULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Lipase ≤ 1.5 x the ULN
  • Creatinine ≤ 1.5 x the ULN
  • Platelet count ≥ 100000 /mm3
  • hemoglobin (Hb) ≥ 9 g/dL,
  • absolute neutrophil count (ANC) ≥ 1500/mm3.
  • Blood transfusion to meet the inclusion criteria will not be allowed.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the site principal investigator or a designated associate.
  • Subject must be able to swallow and retain oral medication.
  • If the patient is enrolled at MSK he/she must consent to a pre and post treatment biopsy (or have archived tissue available for the pretreatment analysis). Pretreatment archival tissue for patients enrolled outside of MSK should be submitted to MSK. If there is no archival tissue available, a repeat biopsy is not required for non-MSK patients.

Exclusion Criteria:

  • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management.
  • Active or clinically significant cardiac disease including:
  • Congestive heart failure - New York Heart Association (NYHA) > Class II.
  • Active coronary artery disease.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
  • Subjects with any previously untreated or concurrent cancer that is distinct in primary site or
  • Recent history of prior cancer except cervical cancer in situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before enrollment are allowed.
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Ongoing infection > Grade 2 NCI-CTCAE v4.0.
  • Symptomatic metastatic brain or meningeal tumors.
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture.
  • Patients with seizure disorder requiring medication.
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea).
  • History of organ allograft (including corneal transplant).
  • Any malabsorption condition.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.

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): NCT02023333


Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
United States, New York
Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Cancer Center Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bayer
State University of New York - Downstate Medical Center
Queens Cancer Center of Queens Hospital
Investigators
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Principal Investigator: Andrea Cercek, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02023333    
Other Study ID Numbers: 13-211
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Regorafenib
Performance Status
13-211
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms