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

February 7, 2008 updated by: Millennium Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

January 21, 2003

First Submitted That Met QC Criteria

January 21, 2003

First Posted (Estimate)

January 22, 2003

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M34102-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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