A Translational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ASCENT) - Full Text View

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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

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:	November 2017
Estimated Primary Completion Date:	November 2017 (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: Please reference Study ID Number: ML25753 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Australia
	Recruiting
Brisbane, Australia, 4029
	Recruiting
Campbelltown, Australia, 2560
	Recruiting
Camperdown, Australia, 2050
	Recruiting
Coffs Harbour, Australia, 2450
	Recruiting
Darlinghurst, Australia, 2010
	Recruiting
Elizabeth Vale, Australia, 5112
	Recruiting
Footscray, Australia, 3011
	Recruiting
Heidelberg, Australia, 3084
	Recruiting
Launceston, Australia, 7250
	Recruiting
Murdoch, Australia, 6150
	Recruiting
North Adelaide, Australia, 5006
	Recruiting
St Leonards, Australia, 2065
	Recruiting
Subiaco, Australia, 6008
	Recruiting
Townsville, Australia, 4814
	Recruiting
Wahroonga, Australia, 2076
	Recruiting
Woden, Australia, 2606

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):

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.

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:	May 7, 2013
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 May 16, 2013