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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
  Purpose
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.

Condition Intervention Phase
Colorectal Neoplasms Drug: Oxaliplatin Drug: Capecitabine Drug: Bevacizumab Drug: Leucovorin Drug: 5-Fluouracil Drug: Irinotecan Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™) [ASCENT]

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 128
Actual Study Start Date: June 26, 2012
Study Completion Date: September 30, 2016
Primary Completion Date: September 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01588990


Locations
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia, 2560
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
St Vincent'S Hospital; Clinical Oncology
Darlinghurst, New South Wales, Australia, 2010
Mid North Coast Cancer Institute
Port Macquarie, New South Wales, Australia, 2444
Royal North Shore Hospital; Department of Medical Oncology
St Leonards, New South Wales, Australia, 2065
Sydney Adventist Hospital; Clinical Trial Unit
Sydney, New South Wales, Australia, 2076
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4029
Rockhampton Hospital
Rockhampton, Queensland, Australia, 4700
The Townsville Hospital; Townsville Cancer Centre
Townsville, Queensland, Australia, 4812
Australia, South Australia
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
Elizabeth Vale, South Australia, Australia, 5112
Calvary North Adelaide; North Adeliade Oncology Centre
North Adelaide, South Australia, Australia, 5006
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
Sunshine Hospital; Oncology Research
St Albans, Victoria, Australia
Australia, Western Australia
St John of God Murdoch Hospital; Oncology West
Murdoch, Western Australia, Australia, 6150
St John of God Hospital; Bendat Cancer Centre
Subiaco, Western Australia, Australia, 6008
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01588990     History of Changes
Other Study ID Numbers: ML25753
First Submitted: April 27, 2012
First Posted: May 1, 2012
Last Update Posted: October 16, 2017
Last Verified: July 2017

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
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents