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A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen


Participants were

- randomized at baseline (treatment was initiated with 3 days of randomization)

- administered treatment in cycles of 14-days till a study withdrawal criterion was met

- followed up 30 days after discontinuation of treatment, and every 8 weeks until death
or end of study.

The criteria for discontinuation of study treatment for a participant are:

- participant (or legal representative) chose to withdraw from treatment

- the investigator thought that continuation of the study would be detrimental to the
participants well-being due to

- disease progression

- unacceptable AEs

- intercurrent illnesses

- non-compliance to the study protocol

- participant was lost to follow-up

- participant was unblinded for the investigational treatment


Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:



- Histologically or cytologically proven adenocarcinoma of the colon or rectum

- Metastatic disease that is not amenable to potentially curative treatment

- One and only one prior line of treatment for metastatic disease. This prior line
should be an oxaliplatin based chemotherapy (participants who relapse within 6 months
of completion of oxaliplatin based adjuvant chemotherapy are eligible)

- Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

- Prior therapy with irinotecan

- Eastern Cooperative Oncology Group performance status >2

The above information is not intended to contain all considerations relevant to
participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.

Outcome Time Frame:

From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10262

NCT ID:

NCT00561470

Start Date:

November 2007

Completion Date:

June 2012

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • colorectal cancer
  • metastatic
  • anti-angiogenic
  • irinotecan
  • 5-FU
  • FOLFIRI
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Sanofi-Aventis Investigational Site Number 840010Chicago, Illinois  60611
Sanofi-Aventis Investigational Site Number 840046Los Angeles, California  90033
Sanofi-Aventis Investigational Site Number 840001Oceanside, California  92056
Sanofi-Aventis Investigational Site Number 840026High Point, North Carolina  27262
Sanofi-Aventis Investigational Site Number 840006San Diego, California  92103
Sanofi-Aventis Investigational Site Number 840119Birmingham, Alabama  35203
Sanofi-Aventis Investigational Site Number 840074Muscle Shoals, Alabama  35661
Sanofi-Aventis Investigational Site Number 840093Hot Springs, Arizona  71913
Sanofi-Aventis Investigational Site Number 840080Anaheim, California  92801
Sanofi-Aventis Investigational Site Number 840076Fountain Valley, California  92708
Sanofi-Aventis Investigational Site Number 840120Fountain Valley, California  92708
Sanofi-Aventis Investigational Site Number 840073Greenbrae, California  94904-2007
Sanofi-Aventis Investigational Site Number 840101Hayward, California  94545
Sanofi-Aventis Investigational Site Number 840116Loma Linda, California  92354
Sanofi-Aventis Investigational Site Number 840048Long Beach, California  90813
Sanofi-Aventis Investigational Site Number 840201Oakland, California  94611
Sanofi-Aventis Investigational Site Number 840901Roseville, California  95678
Sanofi-Aventis Investigational Site Number 840301Sacramento, California  95825
Sanofi-Aventis Investigational Site Number 840042Sacramento, California  95816
Sanofi-Aventis Investigational Site Number 840112Salinas, California  93901-3906
Sanofi-Aventis Investigational Site Number 840406San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840506San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840606San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840806San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840906San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840306San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840706San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840106San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840206San Diego, California  92102
Sanofi-Aventis Investigational Site Number 840401San Francisco, California  94115
Sanofi-Aventis Investigational Site Number 840601San Jose, California  95119
Sanofi-Aventis Investigational Site Number 840501Santa Clara, California  95051
Sanofi-Aventis Investigational Site Number 840801South San Francisco, California  94080
Sanofi-Aventis Investigational Site Number 840701Walnut Creek, California  94596
Sanofi-Aventis Investigational Site Number 840071Stamford, Connecticut  06902
Sanofi-Aventis Investigational Site Number 840014Newark, Delaware  19718
Sanofi-Aventis Investigational Site Number 840089Boynton Beach, Florida  33435
Sanofi-Aventis Investigational Site Number 840031Gainesville, Florida  32610
Sanofi-Aventis Investigational Site Number 840041Gainesville, Florida  32608
Sanofi-Aventis Investigational Site Number 840122Miami, Florida  33176
Sanofi-Aventis Investigational Site Number 840079The Villages, Florida  32159
Sanofi-Aventis Investigational Site Number 840087Chicago, Illinois  60616
Sanofi-Aventis Investigational Site Number 840019Decatur, Illinois  62526
Sanofi-Aventis Investigational Site Number 840115Elk Grove Village, Illinois  60007
Sanofi-Aventis Investigational Site Number 840113Quincy, Illinois  62301
Sanofi-Aventis Investigational Site Number 840072Indianapolis, Indiana  46254
Sanofi-Aventis Investigational Site Number 840047Indianapolis, Indiana  46260
Sanofi-Aventis Investigational Site Number 840034Munster, Indiana  46321
Sanofi-Aventis Investigational Site Number 840088Louisville, Kentucky  40202
Sanofi-Aventis Investigational Site Number 840096Paducah, Kentucky  42003
Sanofi-Aventis Investigational Site Number 840043Baton Rouge, Louisiana  70809
Sanofi-Aventis Investigational Site Number 840084Metairie, Louisiana  70006
Sanofi-Aventis Investigational Site Number 840015New Orleans, Louisiana  70121
Sanofi-Aventis Investigational Site Number 840070Rockville, Maryland  20850
Sanofi-Aventis Investigational Site Number 840029Salisbury, Maryland  21801
Sanofi-Aventis Investigational Site Number 840053Pontiac, Michigan  48341
Sanofi-Aventis Investigational Site Number 840021St Louis Park, Minnesota  55416
Sanofi-Aventis Investigational Site Number 840081Kansas City, Missouri  64128
Sanofi-Aventis Investigational Site Number 840052St Louis, Missouri  63104
Sanofi-Aventis Investigational Site Number 840114St. Louis, Missouri  63136
Sanofi-Aventis Investigational Site Number 840049Las Vegas, Nevada  89106
Sanofi-Aventis Investigational Site Number 840044Albuquerque, New Mexico  87131
Sanofi-Aventis Investigational Site Number 840036Albany, New York  12206
Sanofi-Aventis Investigational Site Number 840094Lake Success, New York  11042
Sanofi-Aventis Investigational Site Number 840097Syracuse, New York  13210
Sanofi-Aventis Investigational Site Number 840017Syracuse, New York  13210
Sanofi-Aventis Investigational Site Number 840035Burlington, North Carolina  27215
Sanofi-Aventis Investigational Site Number 840024Charlotte, North Carolina  28204
Sanofi-Aventis Investigational Site Number 840005Goldsboro, North Carolina  27534
Sanofi-Aventis Investigational Site Number 840004Hendersonville, North Carolina  28791
Sanofi-Aventis Investigational Site Number 840075Winston-Salem, North Carolina  27103
Sanofi-Aventis Investigational Site Number 840098Cincinnati, Ohio  45219
Sanofi-Aventis Investigational Site Number 840011Kettering, Ohio  45429
Sanofi-Aventis Investigational Site Number 840086Middletown, Ohio  45042
Sanofi-Aventis Investigational Site Number 840008Toledo, Ohio  43623
Sanofi-Aventis Investigational Site Number 840039Portland, Oregon  97227
Sanofi-Aventis Investigational Site Number 840118Bethlehem, Pennsylvania  18015
Sanofi-Aventis Investigational Site Number 840033Philadelphia, Pennsylvania  19107
Sanofi-Aventis Investigational Site Number 840012Pittsburgh, Pennsylvania  15212
Sanofi-Aventis Investigational Site Number 840082Pawtucket, Rhode Island  02860
Sanofi-Aventis Investigational Site Number 840095Woonsocket, Rhode Island  02895
Sanofi-Aventis Investigational Site Number 840085Charleston, South Carolina  29403
Sanofi-Aventis Investigational Site Number 840037Spartanburg, South Carolina  29303
Sanofi-Aventis Investigational Site Number 840078Corpus Christi, Texas  78405
Sanofi-Aventis Investigational Site Number 840117Temple, Texas  76508
Sanofi-Aventis Investigational Site Number 840099Seattle, Washington  98115
Sanofi-Aventis Investigational Site Number 840002Marshfield, Wisconsin  54449