Text Size

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

This study is not yet open for participant recruitment.
Verified March 2011 by Martin-Luther-Universität Halle-Wittenberg
Sponsor:
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01321957
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention Phase
Colorectal Cancer Metastatic
 Drug: Oxaliplatin, 5FU/LV, Bevacizumab
Drug: 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • progression free survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety assessments will include physical examinations, vital signs, clinical laboratory profile and monitoring of adverse events [ Time Frame: whole study, every two weeks ] [ Designated as safety issue: Yes ]
  • tumour response according to RECIST v 1.1 [ Time Frame: every two monthsfor the first 6 months and afterwards every 3months. ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: during treatment period every 8/12 weeks and at the end of treatment ] [ Designated as safety issue: Yes ]
    QoL will be assessed using the EORTC QLQ-C30 and the module CR29 at baseline,

  • Incidence and survival (PFS and OS) [ Time Frame: Retrospective analysis ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: May 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FOLFOX+Bevacizumab 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)
Experimental: FOLFOX+Bevacizumab+Irinotecan 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321957

Contacts
Contact: KKS Halle +49 345 557 4908 Aio0209@kks-halle.de

Locations
Germany
Martin-Luther-Universität Halle-Wittenberg Not yet recruiting
Halle/Saale, Germany, 06097
Principal Investigator: Hans-Joachim Schmoll, Prof. Dr. med            
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
  More Information

No publications provided by Martin-Luther-Universität Halle-Wittenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. med. Hans-Joachim Schmoll, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01321957     History of Changes
Other Study ID Numbers: AIO-0209
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
 Bevacizumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013