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FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

7. mai 2015 oppdatert av: SCRI Development Innovations, LLC

A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer. For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection. Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI. Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS. In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • NEA Baptist Clinic
    • Florida
      • Ft. Myers, Florida, Forente stater, 33916
        • Florida Cancer Specialists
      • Orlando, Florida, Forente stater, 32804
        • Florida Hospital Cancer Institute
      • St. Petersburg, Florida, Forente stater, 33705
        • Florida Cancer Specialists
    • Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Northeast Georgia Medical Center
    • Indiana
      • Terre Haute, Indiana, Forente stater, 47802
        • Providence Medical Group
      • Terre Haute, Indiana, Forente stater, 47802
        • Hope Cancer Center
    • Maryland
      • Bethesda, Maryland, Forente stater, 20817
        • Center for Cancer and Blood Disorders
    • New Hampshire
      • Portsmouth, New Hampshire, Forente stater, 03801
        • Portsmouth Regional Hospital
    • New Jersey
      • Morristown, New Jersey, Forente stater, 07960
        • Hematology-Oncology Associates of Northern NJ
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Oncology Hematology Care, Inc
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404
        • Chattanooga Oncology Hematology Associates
      • Collierville, Tennessee, Forente stater, 38017
        • Family Cancer Center
      • Nashville, Tennessee, Forente stater, 37203
        • Tennessee Oncology, PLLC
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • The Center for Cancer and Blood Disorders

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
  2. Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
  3. Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
  4. Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).

  6. Laboratory values as follows:

    ANC greater than 1500/μL

    Hgb greater than9 g/dL

    Platelets greater than 100,000/μL

    AST/SGOT less than 5.0 x ULN

    ALT/SGPT less than or equal to 5.0 x ULN

    Alk Phos less than or equal to 5.0 x ULN

    Bilirubin less than or equal to 1.5 x ULN

    Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min

    Magnesium LLN

  7. Patient must have a life expectancy of greater than 12 weeks.
  8. Patient must be greater than or equal to 18 years of age.
  9. Patient must be accessible for treatment and follow-up.
  10. Women of childbearing potential must have a negative serum or urine pregnancy test performed less than or equal to 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  11. Patient must be able to understand the nature of the study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
  2. Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
  3. Any detectable metastases in areas other than the liver.
  4. Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
  5. Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis [DVT]) will be excluded.
  6. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
  7. History of Gilbert's disease.
  8. History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
  9. Serious cardiac arrhythmia requiring medication.
  10. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
  11. Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
  12. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  13. Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
  14. Past or current history of neoplasm other than the entry diagnosis with the exception of treated non melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS greater than or equal to 5 years.
  15. Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.
  16. Female patients who are pregnant or lactating.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FOLFOXIRI+panitumumab regimen

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil
Legemiddel: Panitumumab
6 mg/kg, 60-90 minute IV infusion every 2 weeks
Andre navn:
  • Kombinert modalitetsbehandling
Legemiddel: Oxaliplatin
85 mg/m2, 2-hour IV infusion every 2 weeks
Andre navn:
  • Kombinert modalitetsbehandling
Legemiddel: Irinotecan
125 mg/m2, 1-hour IV infusion every 2 weeks
Andre navn:
  • Kombinert modalitetsbehandling
Legemiddel: Leucovorin
200 mg/m2, 2-hour IV infusion every 2 weeks
Andre navn:
  • Kombinert modalitetsbehandling
Legemiddel: 5-Fluorouracil
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
Andre navn:
  • Kombinert modalitetsbehandling

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: 18 months
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total overlevelse (OS)
Tidsramme: 18 måneder
Hvor lang tid, i måneder, som pasienter var i live fra første dato for protokollbehandling til døden
18 måneder
Progression-free Survival (PFS)
Tidsramme: 18 months
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
18 months
R0 Resection Rate
Tidsramme: 18 months
To determine the rate of complete (R0) resection for patients treated with this regimen.
18 months
To Determine the Acute Toxicity Produced by This Regimen.
Tidsramme: 18 months
The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SCRI Development Innovations, LLC

Samarbeidspartnere

Amgen

Etterforskere

  • Studiestol: Johanna Bendell, MD, SCRI Development Innovations, LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2010

Primær fullføring (Faktiske)

1. mars 2014

Studiet fullført (Faktiske)

1. mars 2014

Datoer for studieregistrering

Først innsendt

15. oktober 2010

Først innsendt som oppfylte QC-kriteriene

20. oktober 2010

Først lagt ut (Anslag)

22. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCRI GI 134

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