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

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588990
First received: April 27, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival in patients with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: XELOX plus Avastin (bevacizumab), or mFOLFOX6 plus Avastin administered until first disease progression. Patients will then continue with Phase B treatment: FOLFIRI plus Avastin until second disease progression. The anticipated time on study treatment is 4 years.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: XELOX
Drug: mFOLFOX6
Drug: FOLFIRI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Prognostic value of the host inflammatory response as assessed by the neutrophil/lymphocyte ratio on progression-free survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival during Phase A [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival during Phase B [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Time to failure of strategy [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Duration of disease control [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival from the start of treatment to study completion [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Survival beyond 1st progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival during Phase B [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Rate of liver resection [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase A Treatment Drug: bevacizumab [Avastin]
7.5 mg/kg intravenously on Day 1 of every 3 weeks cycle until 1st disease progression
Drug: XELOX
Oxaliplatin 130 mg/m2 intravenously on Day 1, capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of every 3 weeks cycle until 1st disease progression
Experimental: Alternative Phase A Treatment Drug: bevacizumab [Avastin]
5.0 mg/kg intravenously on Day 1 every 2 weeks until 1st disease progression
Drug: mFOLFOX6
Oxaliplatin 85 mg/m2 intravenously on Day 1, leucovorin 400 mg/m2 intravenously on Day 1, fluorouracil 400 mg/m2 on Day 1, fluorouracil 2400 mg/m2 intravenous infusion on Day 1 every two weeks until 1st disease progression
Experimental: Phase B Treatment Drug: bevacizumab [Avastin]
5.0 mg/kg intravenously on Day 1 every 2 weeks until 2nd disease progression
Drug: FOLFIRI
Irinotecan 180 mg/m2 intravenously on Day 1, leucovorin 400 mg/m2 on Day 1, fluorouracil 400 mg/m2 on Day 1, fluorouracil 2400 mg/m2 intravenous infusion on Day 1 every 2 weeks until 2nd disease progression

  Eligibility

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

Inclusion Criteria:

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

  • Adult patients, >/= 18 years of age
  • Previously untreated metastatic colorectal cancer and not a candidate for curative resection
  • WHO performance status of 0-1
  • Life expectancy of >/= 3 months
  • Eligible for XELOX, mFOLFOX6, FOLFIRI and Avastin treatment in accordance with local standards of care and pharmaceutical benefits scheme

Additional inclusion criteria for patients 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 patients, and patients 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 (patients 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 patients 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588990

Contacts
Contact: Reference Study ID Number: ML25753 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Australia, Australian Capital Territory
Recruiting
Woden, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Recruiting
Campbelltown, New South Wales, Australia, 2560
Recruiting
Camperdown, New South Wales, Australia, 2050
Recruiting
Darlinghurst, New South Wales, Australia, 2010
Recruiting
Port Macquarie, New South Wales, Australia, 2444
Recruiting
St Leonards, New South Wales, Australia, 2065
Recruiting
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Recruiting
Brisbane, Queensland, Australia, 4029
Recruiting
Townsville, Queensland, Australia, 4812
Australia, South Australia
Active, not recruiting
Elizabeth Vale, South Australia, Australia, 5112
Recruiting
North Adelaide, South Australia, Australia, 5006
Australia, Tasmania
Recruiting
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Recruiting
Footscray, Victoria, Australia, 3011
Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Recruiting
Murdoch, Western Australia, Australia, 6150
Recruiting
Subiaco, Western Australia, Australia, 6008
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: NCT01588990     History of Changes
Other Study ID Numbers: ML25753
Study First Received: April 27, 2012
Last Updated: April 7, 2014
Health Authority: Australia: Therapeutic Goods Administration

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 April 17, 2014