Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC) (SAFE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00862342
First received: March 13, 2009
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.

The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Bevacizumab (Avastin)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Toxicity profiles [ Time Frame: 2 or 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy
Drug: Bevacizumab (Avastin)
Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)
Other Name: Bevacizumab (Avastin)

Detailed Description:

Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.

  Eligibility

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

Inclusion Criteria:

  • Histologically documented colorectal adenocarcinoma
  • Progression during first-line bevacizumab containing chemotherapy within 3 months
  • No serious toxicity to bevacizumab of 1st line treatment
  • Unresectable metastases
  • Uni-dimensional measurable lesion(s) by RECIST
  • Age over 18 years old
  • ECOG 0-2
  • Adequate organ functions by clinical laboratory exams

Exclusion Criteria:

  • Other tumor type than adenocarcinoma
  • CNS metastases
  • GI bleeding
  • Hypersensitivity to any of chemotherapeutic agents
  • Prior use of cetuximab or other targeted agents other than bevacizumab
  • Major surgery within 6 weeks
  • Other serious illness
  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: NCT00862342

Locations
Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Tae Won Kim, M.D. Asan Medical Center
  More Information

Publications:
Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00862342     History of Changes
Other Study ID Numbers: AMC-2008-0487
Study First Received: March 13, 2009
Last Updated: July 16, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
colorectal cancer
Bevacizumab

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 July 23, 2014