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A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00700102
First received: June 17, 2008
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will evaluate the efficacy and safety of adding Avastin (bevacizumab) to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1 will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Colorectal Cancer
 Drug: bevacizumab [Avastin]
Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
Drug: FUFOX, FOLFOX, CAPOX or XELOX
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival (time from randomization to death of any cause) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival from time of starting first-line therapy [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (after first progression) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Response rate, tumor assessments according to RECIST criteria [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Enrollment: 821
Study Start Date: February 2006
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy 1 + Avastin Drug: bevacizumab [Avastin]
5mg/kg iv on days 1 and 14 of each 4 week cycle, or 7.5mg/kg on days 1 and 22 of each 6 week cycle.
Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
As prescribed
Experimental: Chemotherapy 2 + Avastin Drug: bevacizumab [Avastin]
5mg/kg iv on days 1 and 14 of each 4 week cycle, or 7.5mg/kg on days 1 and 22 of each 6 week cycle.
Drug: FUFOX, FOLFOX, CAPOX or XELOX
As prescribed
Active Comparator: Chemotherapy 1 Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
As prescribed
Active Comparator: Chemotherapy 2 Drug: FUFOX, FOLFOX, CAPOX or XELOX
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • Metastatic colorectal cancer and disease progression
  • Previously treated with first-line chemotherapy plus Avastin
  • ECOG <=2.

Exclusion Criteria:

  • Diagnosis of progression of disease more than 3 months after last Avastin administration
  • First-line patients with progression-free survival in first-line of <3 months
  • Patients receiving less than 3 consecutive months of Avastin in first-line therapy
  • Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
  • Clinically significant cardiovascular disease within 6 months prior to start of study treatment
  • Known CNS disease, except for treated CNS metastases as defined by protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700102

  Show 300 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00700102     History of Changes
Other Study ID Numbers: ML18147
Study First Received: June 17, 2008
Last Updated: May 13, 2013
Health Authority: Germany: Ethics Commission

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013