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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588990
First received: April 27, 2012
Last updated: November 24, 2014
Last verified: November 2014

April 27, 2012
November 24, 2014
June 2012
August 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01588990 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Translational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ASCENT)
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 re lationship of the markers of inflammation and progression-free survival in patie nts with previously untreated metastatic colorectal cancer. The study consists o f two phases: Phase A treatment: XELOX plus Avastin (bevacizumab), or mFOLFOX6 p lus Avastin administered until first disease progression. Patients will then con tinue with Phase B treatment: FOLFIRI plus Avastin until second disease progress ion. The anticipated time on study treatment is 4 years.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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: 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
  • Drug: bevacizumab [Avastin]
    5.0 mg/kg intravenously 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 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: Alternative Phase A Treatment
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: mFOLFOX6
  • Experimental: Phase A Treatment
    Interventions:
    • Drug: XELOX
    • Drug: bevacizumab [Avastin]
  • Experimental: Phase B Treatment
    Interventions:
    • Drug: FOLFIRI
    • Drug: bevacizumab [Avastin]
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.
 
Active, not recruiting
127
August 2016
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01588990
ML25753
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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