Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer (CHARTA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01321957 |
|
Recruitment Status :
Completed
First Posted : March 24, 2011
Last Update Posted : October 25, 2018
|
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Hans-Joachim Schmoll, MD, Martin-Luther-Universität Halle-Wittenberg
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Colorectal Cancer | Drug: Oxaliplatin, 5FU/LV, Bevacizumab Drug: 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study |
| Actual Study Start Date : | May 2011 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | August 15, 2018 |
Resource links provided by the National Library of Medicine
| 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:
|
|
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:
|
Primary Outcome Measures :
- progression free survival rate [ Time Frame: 9 months after first study drug administration ]
Secondary Outcome Measures :
- tumour response according to RECIST v 1.1 [ Time Frame: 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 ]
- Progression free survival rate [ Time Frame: 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 ]
- Adverse events [ Time Frame: 18 months after the date of last study drug administration ]Toxicity of study medication
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321957
Locations
Show 51 study locations
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Roche Pharma AG
Investigators
| Principal Investigator: | Hans-Joachim Schmoll, MD | Universitätsklinikum Halle |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hans-Joachim Schmoll, MD, MD, Martin-Luther-Universität Halle-Wittenberg |
| ClinicalTrials.gov Identifier: | NCT01321957 |
| Other Study ID Numbers: |
AIO-0209 |
| First Posted: | March 24, 2011 Key Record Dates |
| Last Update Posted: | October 25, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab Oxaliplatin Irinotecan Fluorouracil |
Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |