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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

M34102-048

NCT ID:

NCT00051974

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Winship Cancer InstituteAtlanta, Georgia  30322
Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Cedars-Sinai Comprehensive Cancer CenterLos Angeles, California  90048
Duke University Medical CenterDurham, North Carolina  27710
University of Colorado Health Sciences CenterDenver, Colorado  80262
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Sylvester Comprehensive Cancer CenterMiami, Florida  
U of Alambama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294
UCLA Medical Center Thoracic MalignancyLos Angeles, California  90095
Yale University School Of MedicineNew Haven, Connecticut  06520
Univeristy of Florida Shands Cancer CenterGainesville, Florida  32610
Atlanta VAMCDecatur, Georgia  30033
Mass. General Hospital Hem/Onc. AssociatesBoston, Massachusetts  02114
DBA Kansas City Cancer CentersKansas City, Missouri  64154
Washington University, Barnard Cancer CenterSt. Louis, Missouri  63110
Kimmel Cancer Center at JeffersonPhiladelphia, Pennsylvania  19107
Vanderbilt University-Clinical Trials CenterNashville, Tennessee  37232
Hunstman Cancer Institute-University of UtahSalt Lake City, Utah  84112