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Phase 2 Study of VELCADE Alone or VELCADE® Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00051974
Collaborator
(none)
155
Enrollment
20
Locations
7.8
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate how tumors in patients with non-small cell lung cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also to see what effects (good and bad) it has on you and your cancer.

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

Detailed Description

In this study, patients with non-small cell lung cancer that is no longer responding to standard medical treatment with another anti-cancer drug will be randomly chosen to receive treatment with VELCADE alone or VELCADE in combination with docetaxel. Patients have almost equal chance of getting into either of the two treatment arms listed above.

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 2 Study of VELCADE Alone or VELCADE Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Sep 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

    • Inoperable, locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC that has been histologically or cytologically confirmed.

    • No more than 1 prior chemotherapy regimen.

    • 18 years of age or older.

    • Measurable or evaluable disease.

    • KPS ≥70%.

    • Life expectancy greater than 3 months.

    • Female patient is either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study.

    • Male patient agrees to use an acceptable method of birth control for the duration of the study.

    • Provide written informed consent before any study-related procedure not part of normal medical care is conducted.

    • Willing and able to comply with the protocol requirements.

    Exclusion Criteria

    • Peripheral neuropathy of Grade 2 or greater intensity, 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 (ADLs).

    • Grade 3: Sensory loss or paresthesia interfering with ADLs.

    • Grade 4: Permanent sensory loss that interferes with function.

    • Previous treatment with VELCADE.

    • Previous treatment with docetaxel (prior treatment with paclitaxel will be allowed).

    • Chemotherapy within 4 weeks prior to enrollment.

    • Radiation therapy within 4 weeks prior to enrollment.

    • Monoclonal antibodies within 6 weeks prior to enrollment.

    • Any major surgery within 4 weeks prior to enrollment.

    • Inadequate organ function at the Screening visit 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 x the upper limit of the normal range (ULN)

    • Alanine transaminase (ALT) ≥3 times ULN

    • Creatinine ≥1.8 mg/dL

    • Total bilirubin ≥2 times ULN

    • Myocardial infarction within 6 months prior to 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 ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

    • No history of brain metastases or central nervous system disease.

    • Active systemic infection requiring treatment.

    • Treatment for a cancer other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.

    • History of allergic reaction attributable to compounds containing boron or mannitol.

    • 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.

    • 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.

    • 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.

    • Pregnant or breast-feeding female patient. 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 post-menopausal or surgically sterilized women.

    • Currently 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 U of Alambama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 Cedars-Sinai Comprehensive Cancer Center Los Angeles California United States 90048
    3 UCLA Medical Center Thoracic Malignancy Los Angeles California United States 90095
    4 University of Colorado Health Sciences Center Aurora Colorado United States 80010
    5 Yale University School Of Medicine New Haven Connecticut United States 06520
    6 Univeristy of Florida Shands Cancer Center Gainesville Florida United States 32610
    7 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    8 Winship Cancer Institute Atlanta Georgia United States 30322
    9 Atlanta VAMC Decatur Georgia United States 30033
    10 Mass. General Hospital Hem/Onc. Associates Boston Massachusetts United States 02114
    11 DBA Kansas City Cancer Centers Kansas City Missouri United States 64154
    12 St. Louis University Health Sciences Center St. Louis Missouri United States 63110
    13 Washington University, Barnard Cancer Center St. Louis Missouri United States 63110
    14 Carolinas Hematology-Oncology Associates Charlotte North Carolina United States 28203
    15 Duke University Medical Center Durham North Carolina United States 27710
    16 Kimmel Cancer Center at Jefferson Philadelphia Pennsylvania United States 19107
    17 Vanderbilt University-Clinical Trials Center Nashville Tennessee United States 37232
    18 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    19 Hunstman Cancer Institute-University of Utah Salt Lake City Utah United States 84112
    20 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792

    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:
    NCT00051974
    Other Study ID Numbers:
    • M34102-048
    First Posted:
    Jan 22, 2003
    Last Update Posted:
    Feb 11, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Bortezomib

    Study Results

    No Results Posted as of Feb 11, 2008