Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma

Completed · Phase 2

Conditions studied: Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT00051987

Run by

Millennium Pharmaceuticals, Inc.

People needed

175

Starts

2002-12-01

Last updated by the study team

2008-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.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)
• 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.

Where it is running

• Cooper Green Hospital / Jefferson Clinic P.C. — Birmingham, Alabama, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• Arkansas Cancer Center — Pine Bluff, Arkansas, United States
• Alta Bates Comprehensive Cancer Center — Berkley, California, United States
• California Cancer Center — Greenbrae, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• City of Hope Medical Group — Pasadena, California, United States
• H. Lee Moffit Cancer Center — Tampa, Florida, United States
• Rush Cancer Institute — Chicago, Illinois, United States
• Kentuckiana Cancer Institute, PLLC — Louisville, Kentucky, United States
• West Michigan Regional Cancer and Blood Center — Ludington, Michigan, United States
• Bond Clinic Inc. — Rolla, Missouri, United States
• Nevada Cancer Center — Las Vegas, Nevada, United States
• Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• The Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• New York University — New York, New York, United States
• St. Lukes Rossevelt Hospital — New York, New York, United States
• UNC School of Medicine — Chapel Hill, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health Sciences — Portland, Oregon, United States
• Memphis Cancer Center, PC — Memphis, Tennessee, United States
• University of Texas Health Sciences Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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