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A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer (ASCENT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588990
First Posted: May 1, 2012
Last Update Posted: October 16, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
April 27, 2012
May 1, 2012
October 16, 2017
June 26, 2012
September 30, 2016   (Final data collection date for primary outcome measure)
Neutrophil to Lymphocyte Ratio (NLR) for an Association With PFS [ Time Frame: Baseline up to disease progression, death or end of study (up to 4 years) ]
Prognostic value of the host inflammatory response as assessed by the neutrophil/lymphocyte ratio on progression-free survival [ Time Frame: Up to 4 years ]
Complete list of historical versions of study NCT01588990 on ClinicalTrials.gov Archive Site
  • PFS Until First Disease Progression as Assessed by the Investigator Based on RECIST [ Time Frame: Baseline up to disease progression, death or end of study (up to 4 years) ]
  • PFS Until Second Disease Progression as Assessed by the Investigator Based on RECIST [ Time Frame: Baseline up to disease progression, death or end of study (up to 4 years) ]
  • Time to Failure of Strategy [ Time Frame: Baseline up to disease progression, death or end of study (up to 4 years) ]
  • Duration of Disease Control [ Time Frame: From date of first objective response to disease progression, death or end of study (up to 4 years) ]
  • Overall Survival (OS) from the Start of Treatment to Study Completion [ Time Frame: Baseline up to death or end of study (up to 4 years) ]
  • OS Beyond First Disease Progression [ Time Frame: From date of first disease progression up to death or end of study (up to 4 years) ]
  • OS During Phase B [ Time Frame: From date of first disease progression up to second disease progression or death (up to 4 years) ]
  • Percentage of Participants with Best Overall Response [ Time Frame: Baseline up to disease progression, death or end of study (up to 4 years) ]
  • Percentage of Participants who Underwent Liver Resection [ Time Frame: Baseline up to end of study (up to 4 years) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to end of study (up to 4 years) ]
  • Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EuroQoL-5D) [ Time Frame: Baseline, every 8-9 weeks thereafter, safety follow-up (30 days after the last dose of study treatment [up to 4 years]), survival follow-up (up to 4 years) ]
  • Global Utility Score Using the Assessment of Quality of Life - Eight Dimensions (AQoL-8D) [ Time Frame: Baseline, every 8-9 weeks thereafter, safety follow-up (30 days after the last dose of study treatment [up to 4 years]), survival follow-up (up to 4 years) ]
  • Quality of Life (QOL) Assessment Using Functional Assessment of Cancer Therapy-Colorectal (FACT-C) [ Time Frame: Baseline, every 8-9 weeks thereafter, safety follow-up (30 days after the last dose of study treatment [up to 4 years]), survival follow-up (up to 4 years) ]
  • Progression-free survival during Phase A [ Time Frame: Up to 4 years ]
  • Progression-free survival during Phase B [ Time Frame: Up to 4 years ]
  • Time to Failure of Strategy [ Time Frame: Up to 4 years ]
  • Duration of Disease Control [ Time Frame: Up to 4 years ]
  • Overall survival from the start of treatment to study completion [ Time Frame: Up to 4 years ]
  • Survival beyond 1st progression [ Time Frame: Up to 4 years ]
  • Overall survival during Phase B [ Time Frame: Up to 4 years ]
  • Overall response rate [ Time Frame: Up to 4 years ]
  • Rate of liver resection [ Time Frame: Up to 4 years ]
  • Safety: incidence of adverse events [ Time Frame: Up to 4 years ]
Not Provided
Not Provided
 
A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer
An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™) [ASCENT]
This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or modified infusional 5-fluorouracil (5-FU), Leucovorin (LV) and oxaliplatin (mFOLFOX6) plus bevacizmab administered until first disease progression. Participants will then continue with Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second disease progression. The anticipated time on study treatment is 4 years.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Neoplasms
  • Drug: Oxaliplatin
    Participants will receive oxaliplatin 85 milligrams per square meter (mg/m^2) intravenous (IV) on Day 1 of every 2 weeks cycle during alternative phase A treatment or 130 mg/m^2 on Day 1 of every 3 weeks cycle during Phase A treatment.
  • Drug: Capecitabine
    Participants will receive capecitabine 1000 mg/m^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle.
  • Drug: Bevacizumab
    Participants will receive 7.5 mg/kg IV on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
    Other Name: Avastin, RO4876646
  • Drug: Leucovorin
    Participants will receive leucovorin 400 mg/m^2 IV on Day 1 every 2 weeks. Investigators may elect to chose low dose of leucovorin (either 20 mg/m^2 or 50 mg total dose).
  • Drug: 5-Fluouracil
    Participants will receive 5-fluouracil loading dose of 400 mg/m^2 IV on Day 1 followed by 2400 mg/m^2 continuous IV infusion over 46 hours Day 1.
  • Drug: Irinotecan
    Participants will receive irinotecan 180 mg/m^2 IV on Day 1 every 2 weeks.
Experimental: Metastatic Colorectal Cancer Participants
Participants will undergo Phase A followed by Phase B. Participants will receive bevacizumab in combination with XELOX regimen (every 3 weeks) or mFOLFOX regimen (every 2 weeks) until first disease progression or the occurrence of an unmanageable toxicity or withdrawal from the study, in Phase A. Upon documented first disease progression, participants will continue receiving bevacizumab in combination with FOLFIRI (every 2 weeks) until second disease progression, unmanageable toxicity, or withdrawal from study, in Phase B.
Interventions:
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Drug: Bevacizumab
  • Drug: Leucovorin
  • Drug: 5-Fluouracil
  • Drug: Irinotecan
Clarke S, Burge M, Cordwell C, Gibbs P, Reece W, Tebbutt N. An Australian translational study to evaluate the prognostic role of inflammatory markers in patients with metastatic ColorEctal caNcer Treated with bevacizumab (Avastin™) [ASCENT]. BMC Cancer. 2013 Mar 15;13:120. doi: 10.1186/1471-2407-13-120.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
September 30, 2016
September 30, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

For resected primary tumor participants, and patients with primary tumor in situ:

  • Previously untreated metastatic colorectal cancer and not a candidate for curative resection
  • World Health Organization (WHO) performance status of 0-1
  • Life expectancy of greater than or equal to (>/=) 3 months
  • Eligible for XELOX, mFOLFOX6, FOLFIRI and bevacizumab treatment in accordance with local standards of care and pharmaceutical benefits scheme

Additional inclusion criteria for participants with primary tumor in situ:

  • Intact primary tumor of the colon or the rectum not requiring surgical intervention prior to study start
  • Minimal or asymptomatic primary tumor

Exclusion Criteria:

Resected primary tumor participants, and participants with primary tumor in situ:

  • Previous chemotherapy for metastatic colorectal cancer
  • Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start
  • Radiotherapy within 28 days prior to enrolment or not recovered from a radiotherapy
  • History of non-colorectal cancer (participants are eligible if disease-free for more than 5 years and the risk of recurrence is deemed low)
  • Presence of active inflammatory bowel disease
  • History of gastrointestinal perforations
  • Peritoneal disease
  • History of significant bleeding event
  • Significant vascular disease
  • Peripheral arterial thrombosis or other thrombotic event within 6 months before study start

Additional exclusion criteria for participants with primary tumor in situ:

  • Prior endoscopic management of the current tumor
  • Acute diverticulitis
  • Presence of intra-abdominal abscess
  • Active gastroduodenal ulcer
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01588990
ML25753
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP