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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Kolorektala neoplasmer

Intervention / Behandling

Läkemedel: Cetuximab

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

165

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck KGaA, Darmstadt, Germany

Samarbetspartners

Merck Ltd., India

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 november 2009

Primärt slutförande (Faktisk)

31 juli 2013

Avslutad studie (Faktisk)

5 augusti 2014

Studieregistreringsdatum

Först inskickad

28 maj 2010

Först inskickad som uppfyllde QC-kriterierna