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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00051974

Run by

Millennium Pharmaceuticals, Inc.

People needed

155

Starts

2002-12-01

Last updated by the study team

2008-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.