Colorectal CarcinomaPhase 2NCT00051987
Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma
A Phase 2 study testing VELCADE TM (bortezomib) for Injection, or PS-341 in people with Colorectal Carcinoma, run by Millennium Pharmaceuticals, Inc. at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- VELCADE TM (bortezomib) for Injection, or PS-341
- Type of treatment
- Injection or infusion
- How many people
- 175 participants
- Where
- 22 sitesUnited States
- Study dates
- Dec 2002to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Alta Bates Comprehensive Cancer Center
Berkley, California, 94704
Cooper Green Hospital / Jefferson Clinic P.C.
Birmingham, Alabama, 35233
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Rush Cancer Institute
Chicago, Illinois, 60612
Ohio State University Medical Center
Columbus, Ohio, 43210
California Cancer Center
Greenbrae, California, 94904
Nevada Cancer Center
Las Vegas, Nevada, 89109
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
West Michigan Regional Cancer and Blood Center
Ludington, Michigan, 49431
Memphis Cancer Center, PC
Memphis, Tennessee, 38119
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
New York University
New York, New York, 10016
St. Lukes Rossevelt Hospital
New York, New York, 10019
City of Hope Medical Group
Pasadena, California, 91105
Arkansas Cancer Center
Pine Bluff, Arkansas, 71603
Oregon Health Sciences
Portland, Oregon, 97201
Bond Clinic Inc.
Rolla, Missouri, 65402
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
H. Lee Moffit Cancer Center
Tampa, Florida, 33612
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma
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.
Read the detailed description
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.
- Conditions
- Colorectal Carcinoma
- Being tested
- VELCADE TM (bortezomib) for Injection, or PS-341
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADE TM (bortezomib) for Injection, or PS-341Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2003 (estimated)
- Study startDec 2002
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051987
- Sponsor's protocol ID
- M34102-049
- Status last verified
- Feb 2008
- First submitted
- 21 Jan 2003
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00051987
- Acronym / sponsor ID
- M34102-049
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2004 (actual)
- First posted
- 22 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (29 listed)
- Patient has greater than or equal to Grade 2 neuropathy as defined by the NCI Common Toxicity Criteria (CTC):
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VELCADE TM (bortezomib) for Injection, or PS-341 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
Related trials for Colorectal Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VELCADE TM (bortezomib) for Injection, or PS-341 in people with Colorectal Carcinoma, run by Millennium Pharmaceuticals, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.