Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma
A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma
1 other identifier
interventional
175
1 country
22
Brief Summary
The purpose of this study is to evaluate how tumors in patients with colorectal carcinoma respond to treatment with VELCADE alone versus VELCADE given with irinotecan, and also to see what effects (good and bad) it has on you and your cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 21, 2003
CompletedFirst Posted
Study publicly available on registry
January 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFebruary 11, 2008
February 1, 2008
1.2 years
January 21, 2003
February 7, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Patient has histologically confirmed inoperable locally advanced or metastatic CRC.
- Patient has measurable disease.
- Patient is not considered a candidate for immediate curative resection.
- Patient has received no more than 2 prior treatment regimens for metastatic disease, one of which must have contained irinotecan.
- Patient has relapsed or progressed while receiving an irinotecan-containing regimen.
- Patient has KPS of 70% or greater.
- Patient has a life expectancy greater than 3 months.
- Patient is 18 years of age or older.
- Female patient is postmenopausal, surgically sterilized, or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable method of birth control for the duration of the study.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
You may not qualify if:
- Patient has greater than or equal to Grade 2 neuropathy as defined by the NCI Common Toxicity Criteria (CTC):
- Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADL).
- Grade 3: Sensory loss or paresthesia interfering with ADL.
- Grade 4: Permanent sensory loss that interferes with function.
- Patient has previously received treatment with VELCADE.
- Patient has other malignancies except non-melanoma skin cancers and carcinoma of the cervix in situ.
- Patient has received chemotherapy within 4 weeks prior to enrollment.
- Patient has received radiation therapy within 4 weeks prior to enrollment.
- Patient has received monoclonal antibodies within 6 weeks prior to enrollment.
- Patient had major surgery within 4 weeks prior to enrollment.
- Patient has inadequate organ function at Baseline (ie, Day 1 of Cycle 1) as defined by the following laboratory values:
- Platelet count ≤ 100,000 x 109/L
- Hemoglobin ≤ 8.0 g/dL
- Absolute neutrophil count (ANC) ≤ 1.5 x 109/L
- Aspartate transaminase (AST) ≥ 3 times the upper limit of the normal range (ULN)
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Cooper Green Hospital / Jefferson Clinic P.C.
Birmingham, Alabama, 35233, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Arkansas Cancer Center
Pine Bluff, Arkansas, 71603, United States
Alta Bates Comprehensive Cancer Center
Berkley, California, 94704, United States
California Cancer Center
Greenbrae, California, 94904, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
City of Hope Medical Group
Pasadena, California, 91105, United States
H. Lee Moffit Cancer Center
Tampa, Florida, 33612, United States
Rush Cancer Institute
Chicago, Illinois, 60612, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202, United States
West Michigan Regional Cancer and Blood Center
Ludington, Michigan, 49431, United States
Bond Clinic Inc.
Rolla, Missouri, 65402, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
New York University
New York, New York, 10016, United States
St. Lukes Rossevelt Hospital
New York, New York, 10019, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health Sciences
Portland, Oregon, 97201, United States
Memphis Cancer Center, PC
Memphis, Tennessee, 38119, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 21, 2003
First Posted
January 22, 2003
Study Start
December 1, 2002
Primary Completion
March 1, 2004
Last Updated
February 11, 2008
Record last verified: 2008-02