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

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00051987
Collaborator
(none)
175
Enrollment
22
Locations
8
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: VELCADE TM (bortezomib) for Injection, or PS-341
 Phase 2

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

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cooper Green Hospital / Jefferson Clinic P.C. Birmingham Alabama United States 35233
    2 Arizona Cancer Center Tucson Arizona United States 85724
    3 Arkansas Cancer Center Pine Bluff Arkansas United States 71603
    4 Alta Bates Comprehensive Cancer Center Berkley California United States 94704
    5 California Cancer Center Greenbrae California United States 94904
    6 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    7 City of Hope Medical Group Pasadena California United States 91105
    8 H. Lee Moffit Cancer Center Tampa Florida United States 33612
    9 Rush Cancer Institute Chicago Illinois United States 60612
    10 Kentuckiana Cancer Institute, PLLC Louisville Kentucky United States 40202
    11 West Michigan Regional Cancer and Blood Center Ludington Michigan United States 49431
    12 Bond Clinic Inc. Rolla Missouri United States 65402
    13 Nevada Cancer Center Las Vegas Nevada United States 89109
    14 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756
    15 The Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    16 New York University New York New York United States 10016
    17 St. Lukes Rossevelt Hospital New York New York United States 10019
    18 UNC School of Medicine Chapel Hill North Carolina United States 27599
    19 Ohio State University Medical Center Columbus Ohio United States 43210
    20 Oregon Health Sciences Portland Oregon United States 97201
    21 Memphis Cancer Center, PC Memphis Tennessee United States 38119
    22 University of Texas Health Sciences Center at San Antonio San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Millennium Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00051987
    Other Study ID Numbers:
    • M34102-049
    First Posted:
    Jan 22, 2003
    Last Update Posted:
    Feb 11, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Carcinoma
    Colorectal Neoplasms
    Bortezomib

    Study Results

    No Results Posted as of Feb 11, 2008