Back to resultsEfficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer (CHARTA)
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Oxaliplatin, 5FU/LV, Bevacizumab
5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
- Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
- ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
- Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
- Life expectancy > 3 months
- Age ≥ 18 years
Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- 9 g/dl or 5.59 mmol/l
- 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.
- 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
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN
- Signed, written informed consent
Exclusion Criteria:
- Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
- Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
- ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
- Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
- Life expectancy > 3 months
- Age ≥ 18 years
Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- 9 g/dl or 5.59 mmol/l
- 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.
- 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
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN
- Signed, written informed consent
Sites / Locations
- Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
- Knappschaftskrankenhaus Bottrop
- Onkologische Praxis
- Städtisches Klinikum Dessau
- Evangelisches Krankenhhaus Dinslaken
- Gemeinschaftspraxis Hämatologie-Onkologie
- Onkozenrum Dresden
- Onkologie Duisburg
- St. Georg Klinikum Eisenach gGmbH
- Katholisches Krankenhaus St. Johann Nepomuk
- pioh Praxis
- Partnerschaft FÄ für Innere Medizin
- MVZ Osthessen GmbH
- Kreiskrankenhaus Gummersbach GmbH
- Martin-Luther-Universität Halle-Wittenberg
- Marienkrankenhaus Hamburg
- Universitätsklinikum Hamburg-Eppendorf
- Überörtliche Gemeinschaftspraxis für Innere Medizin
- Klinikum Region Hannover GmbH,
- Medizinische Hochschule Hannover
- Praxis Dr. Schröder
- Klinikum Heidenheim
- SP Hämatologie u. Internistische Onkologie
- Onkologische Schwerpunktpraxis im Medicinum
- St. Bernward Krankenhaus
- Sanaklinikum Hof GmbH
- Institut für med. Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung GbR
- St. Cincentius-Kliniken gAG
- Universitätsklinikum Schleswig-Holstein
- Gemeinschaftspraxis für Hämatologie und Onkologie
- Studiengesellschaft Kátay + Reiser GbR
- Praxis für Innere Medizin und Gastroenterologie
- Praxis für Innere Medizin
- Ortenau Klinikum - Lahr Ettenhaim
- Gemeinschaftspraxis Dr. med. Veling-Kaiser
- Medizinisches Versorgungszentrum Mitte
- Onco Studies Lörrach-OSL an der Schwerpunktpraxis Onkologie Dreiländereck
- Klinikum Magdeburg gGmbH
- Universitätsklinikum Magdeburg
- Internistisches Fachzentrum mit Dialyse, Onkologische Praxis am Klinikum
- Friedrich-Ebert-Krankenhaus Neumünster GmbH
- PIUS-Hospital Oldenburg
- Universitätsklinikum Rostock
- MedResearch - Medizinisches Studien- u. Dokumentationszentrum Leipziger Land
- Praxis für Innere Medizin, Hämatololgie und Onkologie
- Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
- Klinikum Mutterhaus der Borromäerinnen gGmbH
- Praxisnetzwerk Hämaologie/Intern. Onkologie
- Ammerland-Klinik GmbH
- Praxisgemeinschaft für Onkologie und Urologie Wilhelmshaven
- Praxis Dr. med. Mathias Schulze
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FOLFOX+Bevacizumab
FOLFOX+Bevacizumab+Irinotecan
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
progression free survival rate
Secondary Outcome Measures
tumour response according to RECIST v 1.1
Secondary resection rate
Progression free survival rate
Overall survival
Adverse events
Toxicity of study medication
Quality of Life evaluated by questionnaire
Quality of Life evaluated using questionnaire EORTC QLQ-30
Full Information
NCT ID
NCT01321957
First Posted
March 23, 2011
Last Updated
October 23, 2018
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT01321957
Brief Title
Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer
Acronym
CHARTA
Official Title
FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
August 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX+Bevacizumab
Arm Type
Active Comparator
Arm Description
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)
Arm Title
FOLFOX+Bevacizumab+Irinotecan
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, 5FU/LV, Bevacizumab
Other Intervention Name(s)
Bevacizumab, Oxaliplatin, I-LV, 5-FU
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
Other Intervention Name(s)
Bevacizumab, Oxaliplatin, I-LV, 5-FU, Irinotecan
Intervention Description
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)
Primary Outcome Measure Information:
Title
progression free survival rate
Time Frame
9 months after first study drug administration
Secondary Outcome Measure Information:
Title
tumour response according to RECIST v 1.1
Time Frame
until progression of disease for a maximum of two years after end of treatment
Title
Secondary resection rate
Time Frame
for a maximum of two years after end of treatment
Title
Progression free survival rate
Time Frame
until progression of disease for a maximum of two years after end of treatment
Title
Overall survival
Time Frame
until death for a maximum of two years after end of treatment
Title
Adverse events
Description
Toxicity of study medication
Time Frame
18 months after the date of last study drug administration
Title
Quality of Life evaluated by questionnaire
Description
Quality of Life evaluated using questionnaire EORTC QLQ-30
Time Frame
Until end of treatment (maximum 2 years after first study drug administration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
Life expectancy > 3 months
Age ≥ 18 years
Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
9 g/dl or 5.59 mmol/l
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.
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
Adequate renal function: Serum creatinine ≤ 1.5 x ULN
Signed, written informed consent
Exclusion Criteria:
Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
Patients with at least one measurable lesion, with size > 1 cm (RECIST v1.1)
ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
Life expectancy > 3 months
Age ≥ 18 years
Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
9 g/dl or 5.59 mmol/l
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.
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
Adequate renal function: Serum creatinine ≤ 1.5 x ULN
Signed, written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Joachim Schmoll, MD
Organizational Affiliation
Universitätsklinikum Halle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
City
Berlin
Country
Germany
Facility Name
Knappschaftskrankenhaus Bottrop
City
Bottrop
Country
Germany
Facility Name
Onkologische Praxis
City
Bottrop
Country
Germany
Facility Name
Städtisches Klinikum Dessau
City
Dessau
Country
Germany
Facility Name
Evangelisches Krankenhhaus Dinslaken
City
Dinslaken
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie-Onkologie
City
Dresden
Country
Germany
Facility Name
Onkozenrum Dresden
City
Dresden
Country
Germany
Facility Name
Onkologie Duisburg
City
Duisburg
Country
Germany
Facility Name
St. Georg Klinikum Eisenach gGmbH
City
Eisenach
Country
Germany
Facility Name
Katholisches Krankenhaus St. Johann Nepomuk
City
Erfurt
Country
Germany
Facility Name
pioh Praxis
City
Frechen
Country
Germany
Facility Name
Partnerschaft FÄ für Innere Medizin
City
Freiberg
Country
Germany
Facility Name
MVZ Osthessen GmbH
City
Fulda
Country
Germany
Facility Name
Kreiskrankenhaus Gummersbach GmbH
City
Gummersbach
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle/Saale
ZIP/Postal Code
06097
Country
Germany
Facility Name
Marienkrankenhaus Hamburg
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Überörtliche Gemeinschaftspraxis für Innere Medizin
City
Hamburg
Country
Germany
Facility Name
Klinikum Region Hannover GmbH,
City
Hannover
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Praxis Dr. Schröder
City
Hannover
Country
Germany
Facility Name
Klinikum Heidenheim
City
Heidenheim
Country
Germany
Facility Name
SP Hämatologie u. Internistische Onkologie
City
Hennigsdorf
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis im Medicinum
City
Hildesheim
Country
Germany
Facility Name
St. Bernward Krankenhaus
City
Hildesheim
Country
Germany
Facility Name
Sanaklinikum Hof GmbH
City
Hof
Country
Germany
Facility Name
Institut für med. Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung GbR
City
Kaiserslautern
Country
Germany
Facility Name
St. Cincentius-Kliniken gAG
City
Karlsruhe
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Köln
Country
Germany
Facility Name
Studiengesellschaft Kátay + Reiser GbR
City
Köln
Country
Germany
Facility Name
Praxis für Innere Medizin und Gastroenterologie
City
Köthen
Country
Germany
Facility Name
Praxis für Innere Medizin
City
Laatzen
Country
Germany
Facility Name
Ortenau Klinikum - Lahr Ettenhaim
City
Lahr
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Veling-Kaiser
City
Landshut
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Mitte
City
Leipzig
Country
Germany
Facility Name
Onco Studies Lörrach-OSL an der Schwerpunktpraxis Onkologie Dreiländereck
City
Lörrach
Country
Germany
Facility Name
Klinikum Magdeburg gGmbH
City
Magdeburg
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Internistisches Fachzentrum mit Dialyse, Onkologische Praxis am Klinikum
City
Memmingen
Country
Germany
Facility Name
Friedrich-Ebert-Krankenhaus Neumünster GmbH
City
Neumünster
Country
Germany
Facility Name
PIUS-Hospital Oldenburg
City
Oldenburg
Country
Germany
Facility Name
Universitätsklinikum Rostock
City
Rostock
Country
Germany
Facility Name
MedResearch - Medizinisches Studien- u. Dokumentationszentrum Leipziger Land
City
Rötha
Country
Germany
Facility Name
Praxis für Innere Medizin, Hämatololgie und Onkologie
City
Schkeuditz
Country
Germany
Facility Name
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
City
Schweinfurt
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen gGmbH
City
Trier
Country
Germany
Facility Name
Praxisnetzwerk Hämaologie/Intern. Onkologie
City
Troisdorf
Country
Germany
Facility Name
Ammerland-Klinik GmbH
City
Westerstede
Country
Germany
Facility Name
Praxisgemeinschaft für Onkologie und Urologie Wilhelmshaven
City
Wilhelmshaven
Country
Germany
Facility Name
Praxis Dr. med. Mathias Schulze
City
Zittau
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
32816630
Citation
Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.
Results Reference
derived
PubMed Identifier
22897915
Citation
Stein A, Glockzin G, Wienke A, Arnold D, Edelmann T, Hildebrandt B, Hollerbach S, Illerhaus G, Konigsrainer A, Richter M, Schlitt HJ, Schmoll HJ. Treatment with bevacizumab and FOLFOXIRI in patients with advanced colorectal cancer: presentation of two novel trials (CHARTA and PERIMAX) and review of the literature. BMC Cancer. 2012 Aug 16;12:356. doi: 10.1186/1471-2407-12-356.
Results Reference
derived
Learn more about this trial
Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer
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