Colorectal Cancer Clinical Trial
Official title:
Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
| Verified date | April 2010 |
| Source | ImClone LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
| Status | Completed |
| Enrollment | 1302 |
| Est. completion date | October 2007 |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic. - Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer. - Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease. Exclusion Criteria: - A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy - Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease - Known or documented brain metastases |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | ImClone Investigational Site | Adelaide | South Australia |
| Australia | ImClone Investigational Site | Perth | Australian Capital Territory |
| Australia | ImClone Investigational Site | South Brisbane | Queensland |
| Australia | ImClone Investigational Site | Sydney | Australian Capital Territory |
| Australia | ImClone Investigational Site | Sydney | New South Wales |
| Australia | ImClone Investigational Site | Wien | |
| Australia | ImClone Investigational Site | Wollongong | New South Wales |
| Austria | ImClone Investigational Site | Graz | |
| Austria | ImClone Investigational Site | Salzburg | |
| Austria | ImClone Investigational Site | Wein | |
| Austria | ImClone Investigational Site | Wien | |
| Belgium | ImClone Investigational Site | Charleroi | |
| Czech Republic | ImClone Investigational Site | Brno | |
| Czech Republic | ImClone Investigational Site | Olomouc | |
| Czech Republic | ImClone Investigational Site | Praha 5 | |
| Finland | ImClone Investigational Site | Helsinki | |
| France | ImClone Investigational Site | Avignon | |
| France | ImClone Investigational Site | Marseille | |
| France | ImClone Investigational Site | Nice | |
| France | ImClone Investigational Site | Saint Herblain | |
| Germany | ImClone Investigational Site | Aschaffenburg | |
| Germany | ImClone Investigational Site | Augsburg | |
| Germany | ImClone Investigational Site | Dessau | |
| Germany | ImClone Investigational Site | Dortmund | |
| Germany | ImClone Investigational Site | Essen | |
| Germany | ImClone Investigational Site | Hamburg | |
| Germany | ImClone Investigational Site | Hanburg | |
| Germany | ImClone Investigational Site | Kaiserslautern | |
| Germany | ImClone Investigational Site | Kassel | |
| Germany | ImClone Investigational Site | Magdeburg | |
| Germany | ImClone Investigational Site | Mainz | |
| Germany | ImClone Investigational Site | Mannheim | |
| Germany | ImClone Investigational Site | Muchnhen | |
| Germany | ImClone Investigational Site | Munchen | |
| Germany | ImClone Investigational Site | Regensburg | |
| Germany | ImClone Investigational Site | Saarbrucken | |
| Germany | ImClone Investigational Site | Stralsund | |
| Germany | ImClone Investigational Site | Stuttgart | |
| Hong Kong | ImClone Investigational Site | Hong Kong | |
| Italy | ImClone Investigational Site | Ancona | |
| Italy | ImClone Investigational Site | Bergamo | |
| Italy | ImClone Investigational Site | Candiolo | |
| Italy | ImClone Investigational Site | Firenze | |
| Italy | ImClone Investigational Site | Genova | |
| Italy | ImClone Investigational Site | Livomo | |
| Italy | ImClone Investigational Site | Milano | |
| Italy | ImClone Investigational Site | Modena | |
| Italy | ImClone Investigational Site | Napoli | |
| Italy | ImClone Investigational Site | Perugia | |
| Italy | ImClone Investigational Site | Reggio Emilia | |
| Italy | ImClone Investigational Site | Roma | |
| Italy | ImClone Investigational Site | Rome | |
| Italy | ImClone Investigational Site | Rozzano | Milano |
| Netherlands | ImClone Investigational Site | Apeldorn | |
| Netherlands | ImClone Investigational Site | Dordrecht | |
| Norway | ImClone Investigational Site | Montebello | Oslo |
| Norway | ImClone Investigational Site | Oslo | |
| Portugal | ImClone Investigational Site | Porto | |
| Slovakia | ImClone Investigational Site | Bratislava | |
| Sweden | ImClone Investigational Site | Lund | |
| Sweden | ImClone Investigational Site | Stockholm | |
| Switzerland | ImClone Investigational Site | Bern | |
| Switzerland | ImClone Investigational Site | Liestal | |
| Switzerland | ImClone Investigational Site | Zurich | |
| United Kingdom | ImClone Investigational Site | Bournemouth | Hampshire |
| United Kingdom | ImClone Investigational Site | Foresterhill | Aberdeenshire |
| United Kingdom | ImClone Investigational Site | Glasgow | Central |
| United Kingdom | ImClone Investigational Site | Guildford | Surrey |
| United Kingdom | ImClone Investigational Site | Hull | Avon |
| United Kingdom | ImClone Investigational Site | London | Greater London |
| United Kingdom | ImClone Investigational Site | Poole | Dorset |
| United Kingdom | ImClone Investigational Site | Sutton | Surrey |
| United States | ImClone Investigational Site | Albany | New York |
| United States | ImClone Investigational Site | Ann Arbor | Michigan |
| United States | ImClone Investigational Site | Arlington | Virginia |
| United States | ImClone Investigational Site | Atlanta | Georgia |
| United States | ImClone Investigational Site | Atlanta | Georgia |
| United States | ImClone Investigational Site | Aurora | Colorado |
| United States | ImClone Investigational Site | Austin | Texas |
| United States | ImClone Investigational Site | Bakersfield | California |
| United States | ImClone Investigational Site | Baltimore | Maryland |
| United States | ImClone Investigational Site | Baton Rouge | Louisiana |
| United States | ImClone Investigational Site | Berkeley | California |
| United States | ImClone Investigational Site | Beverly Hills | California |
| United States | ImClone Investigational Site | Bismarck | North Dakota |
| United States | ImClone Investigational Site | Boston | Massachusetts |
| United States | ImClone Investigational Site | Bronx | New York |
| United States | ImClone Investigational Site | Cincinnati | Ohio |
| United States | ImClone Investigational Site | Cleveland | Ohio |
| United States | ImClone Investigational Site | Columbus | Ohio |
| United States | ImClone Investigational Site | Columbus | Georgia |
| United States | ImClone Investigational Site | Corona | California |
| United States | ImClone Investigational Site | Dallas | Texas |
| United States | ImClone Investigational Site | Danville | Virginia |
| United States | ImClone Investigational Site | Dayton | Ohio |
| United States | ImClone Investigational Site | Denver | Colorado |
| United States | ImClone Investigational Site | Detroit | Michigan |
| United States | ImClone Investigational Site | Durham | North Carolina |
| United States | ImClone Investigational Site | East Setauket | New York |
| United States | ImClone Investigational Site | Fort Myers | Florida |
| United States | ImClone Investigational Site | Fort Myers | Florida |
| United States | ImClone Investigational Site | Frederick | Maryland |
| United States | ImClone Investigational Site | Gilroy | California |
| United States | ImClone Investigational Site | Green Bay | Wisconsin |
| United States | ImClone Investigational Site | Greenbrae | California |
| United States | ImClone Investigational Site | Greenville | North Carolina |
| United States | ImClone Investigational Site | Greenville | South Carolina |
| United States | ImClone Investigational Site | Hershey | Pennsylvania |
| United States | ImClone Investigational Site | High Point | North Carolina |
| United States | ImClone Investigational Site | Honolulu | Hawaii |
| United States | ImClone Investigational Site | Houston | Texas |
| United States | ImClone Investigational Site | Inverness | Florida |
| United States | ImClone Investigational Site | Jackson | Mississippi |
| United States | ImClone Investigational Site | Jacksonville | Florida |
| United States | ImClone Investigational Site | Jacksonville | Florida |
| United States | ImClone Investigational Site | Jacksonville | Florida |
| United States | ImClone Investigational Site | Kansas City | Missouri |
| United States | ImClone Investigational Site | Kansas City | Kansas |
| United States | ImClone Investigational Site | Knoxville | Tennessee |
| United States | ImClone Investigational Site | Lafayette | Louisiana |
| United States | ImClone Investigational Site | Lakeland | Florida |
| United States | ImClone Investigational Site | Latham | New York |
| United States | ImClone Investigational Site | Lexington | Kentucky |
| United States | ImClone Investigational Site | Long Beach | California |
| United States | ImClone Investigational Site | Los Angeles | California |
| United States | ImClone Investigational Site | Los Angeles | California |
| United States | ImClone Investigational Site | Louisville | Kentucky |
| United States | ImClone Investigational Site | Macon | Georgia |
| United States | ImClone Investigational Site | Madison | Wisconsin |
| United States | ImClone Investigational Site | Memphis | Tennessee |
| United States | ImClone Investigational Site | Metairie | Louisiana |
| United States | ImClone Investigational Site | Miami | Florida |
| United States | ImClone Investigational Site | Milwaukee | Wisconsin |
| United States | ImClone Investigational Site | Mineola | New York |
| United States | ImClone Investigational Site | Minneapolis | Minnesota |
| United States | ImClone Investigational Site | Montebello | California |
| United States | ImClone Investigational Site | Naperville | Illinois |
| United States | ImClone Investigational Site | Nashville | Tennessee |
| United States | ImClone Investigational Site | New Haven | Connecticut |
| United States | ImClone Investigational Site | New London | Connecticut |
| United States | ImClone Investigational Site | New Port Richey | Florida |
| United States | ImClone Investigational Site | New York | New York |
| United States | ImClone Investigational Site | Newark | Ohio |
| United States | ImClone Investigational Site | Newport News | Virginia |
| United States | ImClone Investigational Site | Norwich | Connecticut |
| United States | ImClone Investigational Site | Ogden | Utah |
| United States | ImClone Investigational Site | Oklahoma City | Oklahoma |
| United States | ImClone Investigational Site | Orange | California |
| United States | ImClone Investigational Site | Orlando | Florida |
| United States | ImClone Investigational Site | Overland Park | Kansas |
| United States | ImClone Investigational Site | Palm Springs | California |
| United States | ImClone Investigational Site | Philadelphia | Pennsylvania |
| United States | ImClone Investigational Site | Philadelphia | Pennsylvania |
| United States | ImClone Investigational Site | Philadelphia | Pennsylvania |
| United States | ImClone Investigational Site | Pine Bluff | Arkansas |
| United States | ImClone Investigational Site | Pittsburgh | Pennsylvania |
| United States | ImClone Investigational Site | Plano | Texas |
| United States | ImClone Investigational Site | Port St. Lucie | Florida |
| United States | ImClone Investigational Site | Raleigh | North Carolina |
| United States | ImClone Investigational Site | Rancho Mirage | California |
| United States | ImClone Investigational Site | Rexford | New York |
| United States | ImClone Investigational Site | Richmond | Kentucky |
| United States | ImClone Investigational Site | Richmond | Virginia |
| United States | ImClone Investigational Site | Robbinsdale | Minnesota |
| United States | ImClone Investigational Site | Rolla | Missouri |
| United States | ImClone Investigational Site | San Diego | California |
| United States | ImClone Investigational Site | Savannah | Georgia |
| United States | ImClone Investigational Site | Seattle | Washington |
| United States | ImClone Investigational Site | Shreveport | Louisiana |
| United States | ImClone Investigational Site | South Bend | Indiana |
| United States | ImClone Investigational Site | Southfield | Michigan |
| United States | ImClone Investigational Site | Spokane | Washington |
| United States | ImClone Investigational Site | Spokane | Washington |
| United States | ImClone Investigational Site | St. Louis | Missouri |
| United States | ImClone Investigational Site | St. Louis Park | Minnesota |
| United States | ImClone Investigational Site | Stamford | Connecticut |
| United States | ImClone Investigational Site | Stockton | California |
| United States | ImClone Investigational Site | Stony Brook | New York |
| United States | ImClone Investigational Site | Temple | Texas |
| United States | ImClone Investigational Site | Trenton | New Jersey |
| United States | ImClone Investigational Site | Tucker | Georgia |
| United States | ImClone Investigational Site | Tucson | Arizona |
| United States | ImClone Investigational Site | Valhalla | New York |
| United States | ImClone Investigational Site | Vallejo | California |
| United States | ImClone Investigational Site | Voorhees | New Jersey |
| United States | ImClone Investigational Site | Walla Walla | Washington |
| United States | ImClone Investigational Site | Winston-Salem | North Carolina |
| United States | ImClone Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| ImClone LLC | Bristol-Myers Squibb |
United States, Australia, Austria, Belgium, Czech Republic, Finland, France, Germany, Hong Kong, Italy, Netherlands, Norway, Portugal, Slovakia, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | Every 3 months after subject off-treatment | No | |
| Secondary | Progression Free Survival | Q6 Weeks | No | |
| Secondary | Response | Q6 Weeks | No | |
| Secondary | Duration of Response | Q6 Weeks | No | |
| Secondary | Time to Response | Q6 Weeks | No | |
| Secondary | Disease Control Rate | Q6 Weeks | No | |
| Secondary | Safety | Q3 Weeks | Yes | |
| Secondary | Quality of Life | Q6 Weeks | No | |
| Secondary | Health Economics | Q3 Weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
| Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
| Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
| Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
| Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
| Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
| Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
| Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
| Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
| Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
| Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |