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Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma Clinical research trials and Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma. Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma clinical trial. Human subjects often get the best healthcare available for their Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma  Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
For Condition: Colorectal Carcinoma
Status: No longer recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: 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.
Details: In this study, patients with colorectal cancer that is no longer responding to standard medical treatment with irinotecan or an irinotecan containing treatment will be randomized to treatment with VELCADE alone or to treatment with VELCADE in combination with irinotecan.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 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. Exclusion Criteria - 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) *Alanine transaminase (ALT) 3 times ULN *Total bilirubin 1.5 times ULN, unless clearly related to the disease *Calculated or measured creatinine clearance 60 mL/minute. - Patient has had a myocardial infarction within 6 months of enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at Screening has to be documented by the investigator as not medically relevant. - Patient has symptomatic brain metastases. - Patient has an active systemic infection requiring treatment. - Patient has a history of inflammatory bowel disease. - Patient has a history of allergic reaction attributable to compounds containing boron or mannitol. - Patient previously required premature discontinuation of irinotecan therapy because of drug-related toxicity. - Patient is known to be human immunodeficiency virus (HIV)-positive. Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations. - Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. Patients assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local regulations. - Patient has poorly controlled hypertension, diabetes mellitus, or another serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol. - Female patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during the Screening period. Pregnancy testing is not required for postmenopausal or surgically sterilized women. - Patient currently is enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks of enrollment.
Total Enrollment: 175
Location and Contact Information:
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
St. Lukes Rossevelt Hospital
New York City, New York, 10019
United States
Oregon Health Sciences
Portland, Oregon, 97201
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
City of Hope Medical Group
Pasadena, California, 91105
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
West Michigan Regional Cancer and Blood Center
Ludington, Michigan, 49431
United States
Arkansas Cancer Center
Pine Bluff, Arkansas, 71603
United States
New York University
New York City, New York, 10016
United States
California Cancer Center
Greenbrae, California, 94904
United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Bond Clinic Inc.
Rolla, Missouri, 65402
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Cooper Green Hospital / Jefferson Clinic P.C.
Birmingham, Alabama, 35233
United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
United States
Memphis Cancer Center, PC
Memphis, Tennessee, 38119
United States
H. Lee Moffit Cancer Center
Tampa, Florida, 33612
United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: M34102-049;
Study Start Date: December 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051987
Other Colorectal Carcinoma Studies:
1. Phase I Dose-finding Study of E7070 in Combination with Irinotecan
2. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
3. Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
4. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
Related Studies:
Other Colorectal Carcinoma Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Phase 2b Study of VELCADE Alone and VELCADE plus Irinotecan in Patients with Relapsed or Refractory Colorectal Carcinoma
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