Colorectal Cancer Clinical Trial
Official title:
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan, 5-Fluorouracil and Leucovorin
| Verified date | July 2016 |
| Source | Alliance for Clinical Trials in Oncology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Observational |
RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs
and may help doctors plan more effective treatment with fewer side effects.
PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients
with stage III colon cancer who are receiving chemotherapy.
| Status | Completed |
| Enrollment | 308 |
| Est. completion date | November 2006 |
| Est. primary completion date | November 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed stage III adenocarcinoma of the colon - Enrolled on CALGB-89803 and must fall into 1 of the following categories: - Received irinotecan, fluorouracil, and leucovorin calcium and experienced at least 1 of the following: - Grade 3-4 diarrhea - Grade 4 neutropenia - Grade 1 or lower diarrhea AND grade 2 or lower neutropenia - Received fluorouracil and leucovorin calcium and experienced at least 1 of the following: - Grade 3-4 diarrhea - Grade 1 or lower diarrhea AND grade 2 or lower neutropenia PATIENT CHARACTERISTICS: Age - 18 and over |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | McGill University | Montreal | Quebec |
| Puerto Rico | University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | |
| United States | Northeast Alabama Regional Medical Center | Anniston | Alabama |
| United States | Veterans Affairs Medical Center - Asheville | Asheville | North Carolina |
| United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
| United States | Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland |
| United States | Green Mountain Oncology Group | Bennington | Vermont |
| United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Veterans Affairs Medical Center - Buffalo | Buffalo | New York |
| United States | Vermont Cancer Center at University of Vermont | Burlington | Vermont |
| United States | Cooper University Hospital | Camden | New Jersey |
| United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
| United States | Martha Jefferson Hospital | Charlottesville | Virginia |
| United States | Louis A. Weiss Memorial Hospital | Chicago | Illinois |
| United States | MBCCOP - University of Illinois at Chicago | Chicago | Illinois |
| United States | University of Chicago Cancer Research Center | Chicago | Illinois |
| United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
| United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
| United States | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri |
| United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
| United States | NorthEast Oncology Associates | Concord | North Carolina |
| United States | Simmons Cancer Center at University of Texas Southwestern Medical Center - Dalas | Dallas | Texas |
| United States | Veterans Affairs Medical Center - Dallas | Dallas | Texas |
| United States | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania |
| United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
| United States | Veterans Affairs Medical Center - Durham | Durham | North Carolina |
| United States | Elmhurst Hospital Center | Elmhurst | New York |
| United States | Veterans Affairs Medical Center - Fargo | Fargo | North Dakota |
| United States | Cape Fear Valley Health System | Fayetteville | North Carolina |
| United States | Broward General Medical Center | Fort Lauderdale | Florida |
| United States | Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne | Indiana |
| United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
| United States | Memorial Regional Hospital Comprehensive Cancer Center | Hollywood | Florida |
| United States | St. Mary's Medical Center | Huntington | West Virginia |
| United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
| United States | Queens Cancer Center of Queens Hospital | Jamaica | New York |
| United States | Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina |
| United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
| United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Veterans Affairs Medical Center - Las Vegas | Las Vegas | Nevada |
| United States | Norris Cotton Cancer Center at Dartmouth Medical School | Lebanon | New Hampshire |
| United States | Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Baptist Hospital East - Louisville | Louisville | Kentucky |
| United States | CCOP - North Shore University Hospital | Manhasset | New York |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
| United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
| United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Mount Sinai Medical Center, NY | New York | New York |
| United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
| United States | CCOP - Christiana Care Health Services | Newark | Delaware |
| United States | Virginia Oncology Associates - Norfolk | Norfolk | Virginia |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina |
| United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
| United States | Lifespan: The Miriam Hospital | Providence | Rhode Island |
| United States | Ministry Medical Group - Northern Region | Rhinelander | Wisconsin |
| United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
| United States | West Suburban Center for Cancer Care | River Forest | Illinois |
| United States | Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia |
| United States | Saint Anthony Medical Center | Rockford | Illinois |
| United States | Lakeland Medical Center - St. Joseph | Saint Joseph | Michigan |
| United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
| United States | Siteman Cancer Center | Saint Louis | Missouri |
| United States | Veterans Affairs Medical Center - San Diego | San Diego | California |
| United States | UCSF Comprehensive Cancer Center | San Francisco | California |
| United States | Veterans Affairs Medical Center - San Francisco | San Francisco | California |
| United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
| United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
| United States | State University of New York - Upstate Medical University | Syracuse | New York |
| United States | Veterans Affairs Medical Center - Syracuse | Syracuse | New York |
| United States | Lombardi Cancer Center of Georgetown University Medical Center | Washington | District of Columbia |
| United States | Veterans Affairs Medical Center - Washington, DC | Washington | District of Columbia |
| United States | Walter Reed Army Medical Center | Washington | District of Columbia |
| United States | Palm Beach Cancer Institute | West Palm Beach | Florida |
| United States | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont |
| United States | New Hanover Regional Medical Center | Wilmington | North Carolina |
| United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
| United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
| United States | University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | response | Up to 4 years | 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 |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
| Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
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 |