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Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)

perjantai 18. elokuuta 2017 päivittänyt: Hoffmann-La Roche

Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer

This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

280

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Alabama
      • Mobile, Alabama, Yhdysvallat, 36604
        • University of South Alabama; Mitchell Cancer Institute
    • California
      • Long Beach, California, Yhdysvallat, 90806
        • Long Beach Memorial Medical Center; Oncology
      • Los Angeles, California, Yhdysvallat, 90033
        • USC Norris Cancer Center
      • Los Angeles, California, Yhdysvallat, 90033
        • LAC-USC Medical Center
      • Monterey, California, Yhdysvallat, 93940
        • Pacific Cancer Care - Monterey
      • Sacramento, California, Yhdysvallat, 95816
        • Sacramento Center for Hematolo
      • Salinas, California, Yhdysvallat, 93901
        • Pacific Cancer Care
    • Colorado
      • Denver, Colorado, Yhdysvallat, 80205
        • Kaiser Permanente - Franklin
    • Connecticut
      • New Haven, Connecticut, Yhdysvallat, 06520
        • Yale Cancer Center
    • District of Columbia
      • Washington, D.C., District of Columbia, Yhdysvallat, 20016
        • Sibley Memorial Hospital
    • Florida
      • Fort Myers, Florida, Yhdysvallat, 33905
        • Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
      • Saint Petersburg, Florida, Yhdysvallat, 33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Athens, Georgia, Yhdysvallat, 30607
        • University Cancer & Blood Center, LLC
      • Atlanta, Georgia, Yhdysvallat, 30322
        • Emory University Clinic
      • Macon, Georgia, Yhdysvallat, 31201
        • Central Georgia Cancer Care PC
      • Savannah, Georgia, Yhdysvallat, 31405
        • Summit Cancer Care PC
    • Illinois
      • Harvey, Illinois, Yhdysvallat, 60426
        • Ingalls Memorial Hosp
      • Naperville, Illinois, Yhdysvallat, 60540
        • Edward Cancer Center Naperville
      • Plainfield, Illinois, Yhdysvallat, 60585
        • Edward Cancer Center Plainfield
    • Kentucky
      • Lexington, Kentucky, Yhdysvallat, 40536
        • University of Kentucky Medical Center
    • Maryland
      • Baltimore, Maryland, Yhdysvallat, 21231
        • Johns Hopkins Univ; Bunting Blaustein Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Yhdysvallat, 48106
        • St. Joseph Mercy Hospital; Cancer Care Center.
      • Detroit, Michigan, Yhdysvallat, 48201
        • Karmanos Cancer Institute..
    • Missouri
      • Saint Louis, Missouri, Yhdysvallat, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, Yhdysvallat, 68510
        • Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
      • Omaha, Nebraska, Yhdysvallat, 68114
        • Nebraska Methodist Hospital; Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, Yhdysvallat, 03756
        • Dartmouth Hitchcock Med Center
    • Ohio
      • Cincinnati, Ohio, Yhdysvallat, 45242
        • Oncology Hematology Care Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat, 73104
        • University of Oklahoma; Stephenson Oklahoma Canc Ctr
    • Pennsylvania
      • Hershey, Pennsylvania, Yhdysvallat, 17033
        • Milton S. Hershey Medical Center; Penn State Cancer Inst.
    • Tennessee
      • Chattanooga, Tennessee, Yhdysvallat, 37404
        • Chattanooga Oncology and Hematology Associates, PC
      • Germantown, Tennessee, Yhdysvallat, 38138
        • West Clinic
      • Nashville, Tennessee, Yhdysvallat, 37203
        • Sarah Cannon Cancer Center and Research Institute
    • Texas
      • Dallas, Texas, Yhdysvallat, 75390-9063
        • UT Southwestern MC at Dallas
      • Fort Worth, Texas, Yhdysvallat, 76104
        • Ctr For Cancer And Blood Disorders
      • Temple, Texas, Yhdysvallat, 76508
        • Scott and White Hospital; Cancer Center
    • Virginia
      • Richmond, Virginia, Yhdysvallat, 23226
        • Virginia Cancer Institute
    • Washington
      • Kirkland, Washington, Yhdysvallat, 98034
        • Seattle Cancer Care Alliance - Evergreen Health
      • Seattle, Washington, Yhdysvallat, 98109
        • Seattle Cancer Care Alliance
      • Spokane, Washington, Yhdysvallat, 99208
        • Medical Oncology Associates
    • Wisconsin
      • Green Bay, Wisconsin, Yhdysvallat, 54311
        • Vince Lombardi Cancer Center
      • Milwaukee, Wisconsin, Yhdysvallat, 53226
        • Medical College of Wisconsin; Dept Froedtert Clin Can Ctr
      • Wauwatosa, Wisconsin, Yhdysvallat, 53226
        • Aurora Research Institute
    • Wyoming
      • Cheyenne, Wyoming, Yhdysvallat, 82001
        • Cheyenne Oncology & Hematology Associates

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Histologically confirmed colorectal cancer with at least one measurable metastatic lesion by RECIST v 1.1, that is considered unresectable at baseline
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 if age less than (<) 71 years; ECOG status of 0 if age 71 to 75 years
  • Adequate hematological, renal and liver function
  • Participants with treated brain metastases are eligible for study participation; participants may not receive ongoing treatment with steroids at screening, anticonvulsants (at stable dose) are allowed
  • Females of childbearing potential and males must agree to use effective contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
  • Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
  • Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
  • Evidence of Gilbert's Syndrome or homozygosity for the Uridine 5-diphospho-glucuronosyltransferase (UGT) 1A1*28 allele
  • Positive for human immunodeficiency virus (HIV) infection
  • Malignancies other than metastatic colorectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
  • Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
  • Clinically significant third-space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
  • Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
  • Any disease or condition or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of bevacizumab or puts the participant at high risk for treatment-related complications
  • Inadequately controlled hypertension
  • Clinically significant (that is [i.e.] active) cardiovascular disease (For example [e.g.] cerebrovascular accident or myocardial infarction within 6 months prior to randomization), unstable angina, congestive heart failure (New York Heart Association Class >/= II) or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with the administration of the study treatment
  • Known hypersensitivity to bevacizumab or any of its excipients or any other study drug

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Arm A: Concurrent FOLFOXIRI + Bevacizumab
Participants will receive concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Lääke: 5-fluorouracil
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion. Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Lääke: bevacizumab
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Muut nimet:
  • Avastin
Lääke: capecitabine
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Muut nimet:
  • Xeloda
Lääke: irinotecan
Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase.
Lääke: folinic acid
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Muut nimet:
  • leukovoriini
Lääke: oxaliplatin
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
Kokeellinen: Arm B: Sequential FOLFOXIRI + Bevacizumab
Participants will receive alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Lääke: 5-fluorouracil
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion. Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Lääke: bevacizumab
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Muut nimet:
  • Avastin
Lääke: capecitabine
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Muut nimet:
  • Xeloda
Lääke: irinotecan
Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase.
Lääke: folinic acid
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Muut nimet:
  • leukovoriini
Lääke: oxaliplatin
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
Kokeellinen: Arm C: FOLFOX + Bevacizumab
Participants will receive FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
Lääke: 5-fluorouracil
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion. Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Lääke: bevacizumab
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Muut nimet:
  • Avastin
Lääke: capecitabine
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Muut nimet:
  • Xeloda
Lääke: folinic acid
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Muut nimet:
  • leukovoriini
Lääke: oxaliplatin
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
Aikaikkuna: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR
Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
Progression-Free Survival During First-Line Therapy (PFS1)
Aikaikkuna: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm.
Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to PFS2
Aikaikkuna: Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)
Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm.
Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)
Overall Survival (OS)
Aikaikkuna: Randomization until death due to any cause (up to approximately 3 years)
OS was defined as the time from the date of randomization to the date of death from any cause.
Randomization until death due to any cause (up to approximately 3 years)
Proportion of Participants Who Underwent Liver Metastases Resections
Aikaikkuna: Randomization up to approximately 3 years
Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm.
Randomization up to approximately 3 years
Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases
Aikaikkuna: Randomization up to approximately 3 years
The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease.
Randomization up to approximately 3 years
Percentage of Participants With Adverse Events
Aikaikkuna: Randomization up to approximately 3 years
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Randomization up to approximately 3 years

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hoffmann-La Roche

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

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Opintojen ennätyspäivät

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Opi tärkeimmät päivämäärät

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Opintojen valmistuminen (Todellinen)

Maanantai 14. maaliskuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 9. tammikuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 9. tammikuuta 2013

Ensimmäinen Lähetetty (Arvio)

Torstai 10. tammikuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 18. syyskuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 18. elokuuta 2017

Viimeksi vahvistettu

Tiistai 1. elokuuta 2017

Lisää tietoa

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ML28442

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