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

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00051974
First received: January 21, 2003
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: VELCADE™ (bortezomib) for Injection (formerly PS-341)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment: 155
Study Start Date: December 2002
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051974

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

No publications provided

ClinicalTrials.gov Identifier: NCT00051974     History of Changes
Other Study ID Numbers: M34102-048
Study First Received: January 21, 2003
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014