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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitätsklinikum 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 für Hämatologie 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 Borromaerinnen 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Martin-Luther-Universität Halle-Wittenberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans-Joachim Schmoll, MD, Universitätsklinikum 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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