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A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Carcinoma

Thank you

Trial Information

A Randomized, Multicenter, Open-Label, Phase 2b Study of VELCADE Alone and VELCADE Plus Irinotecan in Patients With Relapsed or Refractory Colorectal Carcinoma


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.

Inclusion 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consent may be withdrawn by the patient at any time without prejudice to his or her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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

M34102-049

NCT ID:

NCT00051987

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Colorectal Carcinoma
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
California Cancer CenterFresno, California  93720
Nevada Cancer CenterLas Vegas, Nevada  89109
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Rush Cancer InstituteChicago, Illinois  60612
City of Hope Medical GroupPasadena, California  91105
Ohio State University Medical CenterColumbus, Ohio  43210
Cooper Green Hospital / Jefferson Clinic P.C.Birmingham, Alabama  35233
Arkansas Cancer CenterPine Bluff, Arkansas  71603
H. Lee Moffit Cancer CenterTampa, Florida  33612
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
West Michigan Regional Cancer and Blood CenterLudington, Michigan  49431
Bond Clinic Inc.Rolla, Missouri  65402
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
New York UniversityNew York, New York  10016
St. Lukes Rossevelt HospitalNew York, New York  10019
UNC School of MedicineChapel Hill, North Carolina  27599
Oregon Health SciencesPortland, Oregon  97201
Memphis Cancer Center, PCMemphis, Tennessee  38119
University of Texas Health Sciences Center at San AntonioSan Antonio, Texas  78229