Clinical trial NCT00051974: Phase 2 Study of VELCADE Alone or VELCADE® Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

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