A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700102
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

June 17, 2008
June 18, 2008
July 2, 2015
July 30, 2015
July 30, 2015
February 2006
May 2013   (Final data collection date for primary outcome measure)
Overall Survival: Time From Randomization to Death From Any Cause [ Time Frame: within 6.5 years ]
Progression-free survival [ Time Frame: Event driven ]
Complete list of historical versions of study NCT00700102 on Archive Site
  • Overall Survival: Months From Time of First Line Therapy [ Time Frame: within approximately 9.6 years ]
  • Participants With Progression Free Survival Event [ Time Frame: within 6.5 years ]
  • Progression Free Survival: Time to Event [ Time Frame: within 6.5 years ]
  • Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria [ Time Frame: within 6.5 years ]
  • Response Rate: Participants With Response Status Based on RECIST Criteria [ Time Frame: within 6.5 years ]
    Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
  • Overall survival; response rate. [ Time Frame: Event driven ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]
Not Provided
Not Provided
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Chemotherapy
    As prescribed
  • Drug: Bevacizumab
    Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
    Other Name: Avastin
  • Active Comparator: Chemotherapy
    Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
    Intervention: Drug: Chemotherapy
  • Experimental: Chemotherapy + Bevacizumab
    Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
    • Drug: Chemotherapy
    • Drug: Bevacizumab

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • Metastatic colorectal cancer and disease progression
  • Previously treated with first-line chemotherapy plus Avastin
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria:

  • Diagnosis of progression of disease more than 3 months after last Avastin administration
  • First-line patients with progression-free survival in first-line of <3 months
  • Patients receiving less than 3 consecutive months of Avastin in first-line therapy
  • Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
  • Clinically significant cardiovascular disease within 6 months prior to start of study treatment
  • Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Netherlands,   Norway,   Portugal,   Saudi Arabia,   Spain,   Sweden,   Switzerland
Brazil,   United States
2006-004634-32 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2015

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