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An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer

8. juni 2017 oppdatert av: Merck KGaA, Darmstadt, Germany

This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.

Studieoversikt

Status

Avsluttet

Forhold

Kolorektale neoplasmer

Intervensjon / Behandling

Legemiddel: Cetuximab

Detaljert beskrivelse

Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.

This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.

OBJECTIVES

Primary Objective:

To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Secondary Objective:

To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Studietype

Observasjonsmessig

Registrering (Faktiske)

165

Kontakter og plasseringer

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

Studiesteder

India
- - Delhi, India, 110055
    - Nothern Railway Central Hospital
  - Delhi, India, 110076
    - Indraprastha Apollo Hospital
  - Delhi, India, 110092
    - Shanti Mukand Hospital
  - Delhi, India, 110096
    - Dharamshila Cancer Hospital & Research Centre
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500034
    - Indo- American Cancer Institute & Research Centre
  - Hyderabad, Andhra Pradesh, India, 500063
    - NVS Ramakrishna's Clinic
  - Secunderabad, Andhra Pradesh, India, 500025
    - Dr. Nikhil's Clinic
  - Secunderabad, Andhra Pradesh, India, 500025
    - Nikhil Gharyalpatil's Clinic
- Andrapradesh
  - Hyderabad, Andrapradesh, India, 500001
    - Ravi Kumar's Clinic
  - Hyderabad, Andrapradesh, India, 500008
    - Ambaa Hospitals
  - Hyderabad, Andrapradesh, India, 500059
    - Swarna Sai Hospital
- Bangalore
  - Mangalore, Bangalore, India, 575 001
    - Manipal Centre For Clinical Research
- Calicut
  - Kerala, Calicut, India, 673016
    - Medical College Calicut
- Gujarat
  - Ahmedabad, Gujarat, India, 380009
    - Hemato Oncology Clinic
- Karnataka
  - Hubli, Karnataka, India, 580020
    - Kattimani Oncology Clinic
- Kashmir
  - Srinagar, Kashmir, India, 190001
    - SKIMS
  - Srinagar, Kashmir, India, 190010
    - S. K. I. M. S.
- Madhya Pradesh
  - Bhopal, Madhya Pradesh, India, 462001
    - Dr. T. P. Sahoo's Clinic
- Maharashtra
  - Mumbai, Maharashtra, India, 400014
    - BND Onco Centre
  - Mumbai, Maharashtra, India, 400071
    - Joy Hospital
  - Pune, Maharashtra, India, 411001
    - Ruby Hall Clinic
- Mizoram
  - Aizwal, Mizoram, India, 796 009
    - Grace Nursing Home
- Mumbai
  - Bandra, Mumbai, India, 400050
    - Lilavati Hospital
  - Mahim, Mumbai, India, 400016
    - S.L.Raheja Hospital
- New Delhi
  - Delhi, New Delhi, India, 110044
    - Apollo Cancer Institute
  - Delhi, New Delhi, India, 110085
    - Rajiv Gandhi Cancer Institute & Research
- Punjab
  - Amritsar, Punjab, India, 143004
    - Fortis Escorts Hospital
  - Chandigarh, Punjab, India, 160101
    - Dr. Rajeev Bedi's Clinic
  - Ludhiana, Punjab, India, 141001
    - D.M.C Hospital
  - Mohali, Punjab, India, 160071
    - IVY Hospital
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - SMS Hospital
  - Jaipur, Rajasthan, India, 302004
    - Cancer Clinic
  - Jaipur, Rajasthan, India, 302006
    - Bhagwan Mahaveer Cancer Hospital
  - Jaipur, Rajasthan, India, 302030
    - Bhagwan Mahaveer Cancer Hospital & Research Centre
  - Jodhpur, Rajasthan, India, 3420003
    - Vyas Cancer Care
- Tamilnadu
  - Trivandrum, Tamilnadu, India, 695011
    - TC 14/ 764 Sreemangalam
- Uttar Pradesh
  - Ghaziabad, Uttar Pradesh, India, 201014
    - Shati Gopal Hospital
  - Lucknow, Uttar Pradesh, India, 226007
    - Annapurna Medical and Cancer Relief Society
- West Bengal
  - Kolkata, West Bengal, India, 700026
    - Chittaranjan National Cancer Institute
  - Kolkata, West Bengal, India, 700054
    - Apollo Gleneagles Cancer Hospital

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

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.

Beskrivelse

Inclusion Criteria:

Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
Subjects with KRAS wild-type status of tumour tissue
Chemotherapy naïve subjects
Subject who have signed written informed consent (as per institutional protocol)

Exclusion Criteria:

As per summary of product characteristics of cetuximab

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Safety and tolerability evaluated based on the incidence and severity of AEs. Tidsramme: From baseline to follow-up visit for any ongoing AEs	From baseline to follow-up visit for any ongoing AEs

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Response rate Tidsramme: Baseline to End-of-Study Visit	Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)	Baseline to End-of-Study Visit

Samarbeidspartnere og etterforskere

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

Sponsor

Merck KGaA, Darmstadt, Germany

Samarbeidspartnere

Merck Ltd., India

Etterforskere

Studieleder: Rajiv Rana, MD, Merck Ltd., India

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 (Faktiske)

30. november 2009

Primær fullføring (Faktiske)

31. juli 2013

Studiet fullført (Faktiske)

5. august 2014

Datoer for studieregistrering

Først innsendt

28. mai 2010

Først innsendt som oppfylte QC-kriteriene