Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer (CHARTA)

October 23, 2018 updated by: Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg

FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study

The primary objective of this study is to evaluate the efficacy of Irinotecan in combination with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of patients with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

5-Fluorouracil and oxaliplatin (FOLFOX-Regimen) in combination with bevacizumab is regarded as standard first-line treatment in metastatic colorectal cancer [Saltz et al., 2008]. Current studies established the role of the FOLFOXIRI regimen [Souglakos et al., 2006, Falcone et al., 2007]. A further intensification of the therapy seems feasible yielding response rates up to 84% and a disease control rate up to 100% [Falcone, 2008, Santomaggio, 2009, Masi, 2010]. This trial evaluates the activity of an intensified first-line therapy for metastatic colorectal cancer compared to standard treatment.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
      • Bottrop, Germany
        • Knappschaftskrankenhaus Bottrop
      • Bottrop, Germany
        • Onkologische Praxis
      • Dessau, Germany
        • Städtisches Klinikum Dessau
      • Dinslaken, Germany
        • Evangelisches Krankenhhaus Dinslaken
      • Dresden, Germany
        • Gemeinschaftspraxis Hämatologie-Onkologie
      • Dresden, Germany
        • Onkozenrum Dresden
      • Duisburg, Germany
        • Onkologie Duisburg
      • Eisenach, Germany
        • St. Georg Klinikum Eisenach gGmbH
      • Erfurt, Germany
        • Katholisches Krankenhaus St. Johann Nepomuk
      • Frechen, Germany
        • pioh Praxis
      • Freiberg, Germany
        • Partnerschaft FÄ für Innere Medizin
      • Fulda, Germany
        • MVZ Osthessen GmbH
      • Gummersbach, Germany
        • Kreiskrankenhaus Gummersbach GmbH
      • Halle/Saale, Germany, 06097
        • Martin-Luther-Universität Halle-Wittenberg
      • Hamburg, Germany
        • Universitatsklinikum Hamburg-Eppendorf
      • Hamburg, Germany
        • Marienkrankenhaus Hamburg
      • Hamburg, Germany
        • Überörtliche Gemeinschaftspraxis für Innere Medizin
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hannover, Germany
        • Klinikum Region Hannover GmbH,
      • Hannover, Germany
        • Praxis Dr. Schröder
      • Heidenheim, Germany
        • Klinikum Heidenheim
      • Hennigsdorf, Germany
        • SP Hämatologie u. Internistische Onkologie
      • Hildesheim, Germany
        • St. Bernward Krankenhaus
      • Hildesheim, Germany
        • Onkologische Schwerpunktpraxis im Medicinum
      • Hof, Germany
        • Sanaklinikum Hof GmbH
      • Kaiserslautern, Germany
        • Institut für med. Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung GbR
      • Karlsruhe, Germany
        • St. Cincentius-Kliniken gAG
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Köln, Germany
        • Gemeinschaftspraxis Fur Hamatologie Und Onkologie
      • Köln, Germany
        • Studiengesellschaft Kátay + Reiser GbR
      • Köthen, Germany
        • Praxis fur Innere Medizin und Gastroenterologie
      • Laatzen, Germany
        • Praxis für Innere Medizin
      • Lahr, Germany
        • Ortenau Klinikum - Lahr Ettenhaim
      • Landshut, Germany
        • Gemeinschaftspraxis Dr. med. Veling-Kaiser
      • Leipzig, Germany
        • Medizinisches Versorgungszentrum Mitte
      • Lörrach, Germany
        • Onco Studies Lörrach-OSL an der Schwerpunktpraxis Onkologie Dreiländereck
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg
      • Magdeburg, Germany
        • Klinikum Magdeburg gGmbH
      • Memmingen, Germany
        • Internistisches Fachzentrum mit Dialyse, Onkologische Praxis am Klinikum
      • Neumünster, Germany
        • Friedrich-Ebert-Krankenhaus Neumünster GmbH
      • Oldenburg, Germany
        • Pius-Hospital Oldenburg
      • Rostock, Germany
        • Universitätsklinikum Rostock
      • Rötha, Germany
        • MedResearch - Medizinisches Studien- u. Dokumentationszentrum Leipziger Land
      • Schkeuditz, Germany
        • Praxis für Innere Medizin, Hämatololgie und Onkologie
      • Schweinfurt, Germany
        • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
      • Trier, Germany
        • Klinikum Mutterhaus der Borromäerinnen gGmbH
      • Troisdorf, Germany
        • Praxisnetzwerk Hämaologie/Intern. Onkologie
      • Westerstede, Germany
        • Ammerland-Klinik GmbH
      • Wilhelmshaven, Germany
        • Praxisgemeinschaft für Onkologie und Urologie Wilhelmshaven
      • Zittau, Germany
        • Praxis Dr. med. Mathias Schulze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
  2. Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
  3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
  4. Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
  5. Life expectancy > 3 months
  6. Age ≥ 18 years

  7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin

    • 9 g/dl or 5.59 mmol/l
  8. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
  9. Adequate liver function as measured by serum transaminases (AST & ALT) ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN) and total bilirubin ≤ 1.5 x ULN
  10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
  11. Signed, written informed consent

Exclusion Criteria:

  1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
  2. Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
  3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
  4. Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
  5. Life expectancy > 3 months
  6. Age ≥ 18 years

  7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin

    • 9 g/dl or 5.59 mmol/l
  8. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
  9. Adequate liver function as measured by serum transaminases (AST & ALT) ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN) and total bilirubin ≤ 1.5 x ULN
  10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
  11. Signed, written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FOLFOX+Bevacizumab
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Drug: Oxaliplatin, 5FU/LV, Bevacizumab
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Other Names:
  • 5-FU
  • Bevacizumab
  • Oxaliplatin
  • I-LV
Experimental: FOLFOX+Bevacizumab+Irinotecan
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Drug: 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Other Names:
  • 5-FU
  • Bevacizumab
  • Irinotecan
  • Oxaliplatin
  • I-LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival rate
Time Frame: 9 months after first study drug administration
9 months after first study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumour response according to RECIST v 1.1
Time Frame: until progression of disease for a maximum of two years after end of treatment
until progression of disease for a maximum of two years after end of treatment
Secondary resection rate
Time Frame: for a maximum of two years after end of treatment
for a maximum of two years after end of treatment
Progression free survival rate
Time Frame: until progression of disease for a maximum of two years after end of treatment
until progression of disease for a maximum of two years after end of treatment
Overall survival
Time Frame: until death for a maximum of two years after end of treatment
until death for a maximum of two years after end of treatment
Adverse events
Time Frame: 18 months after the date of last study drug administration
Toxicity of study medication
18 months after the date of last study drug administration
Quality of Life evaluated by questionnaire
Time Frame: Until end of treatment (maximum 2 years after first study drug administration)
Quality of Life evaluated using questionnaire EORTC QLQ-30
Until end of treatment (maximum 2 years after first study drug administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Hans-Joachim Schmoll, MD, Universitatsklinikum Halle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO-0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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