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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 juin 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Tumeurs colorectales

Intervention / Traitement

Médicament: Cetuximab

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

165

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Délai
Safety and tolerability evaluated based on the incidence and severity of AEs. Délai: From baseline to follow-up visit for any ongoing AEs	From baseline to follow-up visit for any ongoing AEs

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Response rate Délai: Baseline to End-of-Study Visit	Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)	Baseline to End-of-Study Visit

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck KGaA, Darmstadt, Germany

Collaborateurs

Merck Ltd., India

Les enquêteurs

Directeur d'études: Rajiv Rana, MD, Merck Ltd., India

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 novembre 2009

Achèvement primaire (Réel)

31 juillet 2013

Achèvement de l'étude (Réel)

5 août 2014

Dates d'inscription aux études

Première soumission

28 mai 2010

Première soumission répondant aux critères de contrôle qualité