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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588990
First received: April 27, 2012
Last updated: November 1, 2016
Last verified: November 2016
  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: FOLFIRI Drug: XELOX Drug: bevacizumab [Avastin] Drug: mFOLFOX6 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: June 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 A Treatment 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
Drug: bevacizumab [Avastin]
7.5 mg/kg intravenously on Day 1 of every 3 weeks cycle until 1st disease progression
Experimental: Phase B Treatment 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
Drug: bevacizumab [Avastin]
5.0 mg/kg intravenously on Day 1 every 2 weeks until 2nd disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588990

Locations
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Campbelltown, New South Wales, Australia, 2560
Camperdown, New South Wales, Australia, 2050
Darlinghurst, New South Wales, Australia, 2010
Port Macquarie, New South Wales, Australia, 2444
St Leonards, New South Wales, Australia, 2065
Sydney, New South Wales, Australia, 2076
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Rockhampton, Queensland, Australia, 4700
Townsville, Queensland, Australia, 4812
Australia, South Australia
Elizabeth Vale, South Australia, Australia, 5112
North Adelaide, South Australia, Australia, 5006
Australia, Tasmania
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
St Albans, Victoria, Australia, 3021
Australia, Western Australia
Murdoch, Western Australia, Australia, 6150
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
Study First Received: April 27, 2012
Last Updated: November 1, 2016

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
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017