A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Compare the tumor response rates (complete and partial response) in patients with
relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with
vs without docetaxel.
Secondary
- Compare time to progression in patients treated with these regimens.
- Compare the overall and 1-year survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
- Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm
I.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional
courses beyond confirmation of CR.
Quality of life is assessed on day 1 of each treatment course (before drug administration)
and at 30 days after the completion of study treatment.
Patients are followed at 30 days and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued
for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Locally advanced (stage IIIB) or metastatic (stage IV) disease
- Inoperable disease
- Relapsed or refractory disease
- Received 1, and only 1, prior chemotherapy regimen for locally advanced or
metastatic disease
- Measurable or evaluable disease
- No symptomatic or inadequately treated brain metastases
- No CNS disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 3 months
Hematopoietic
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
- Absolute neutrophil count greater than 1,500/mm^3
Hepatic
- AST and ALT less than 3 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C negative
Renal
- Creatinine less than 1.8 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No electrocardiographic evidence of acute ischemia or active conduction system
abnormalities
- No poorly controlled hypertension
Immunologic
- No active systemic infection requiring treatment
- No prior allergic reaction attributable to compounds containing boron or mannitol
- HIV negative
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No peripheral neuropathy grade 2 or greater
- No diabetes mellitus
- No other serious medical or psychiatric condition that would preclude study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 6 weeks since prior monoclonal antibody therapy
- No concurrent routine use of colony-stimulating factors (e.g., filgrastim [G-CSF] or
sargramostim [GM-CSF])
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- No prior docetaxel
- Prior paclitaxel allowed
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone
as premedication
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery
- No concurrent surgery for cancer management or treatment
Other
- More than 5 years since prior treatment for any other cancer except basal cell skin
cancer or carcinoma in situ of the cervix
- More than 4 weeks since prior investigational agents
- No prior bortezomib
- No other concurrent investigational agents
- No other concurrent clinical research study participation
- No other concurrent antineoplastic therapy
- No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase
inhibitors (e.g., celecoxib or rofecoxib)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Joan H. Schiller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000305974
NCT ID:
NCT00064012
Start Date:
May 2003
Completion Date:
July 2004
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- recurrent non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
| University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
| Siteman Cancer Center | Saint Louis, Missouri 63110 |
| Kansas City Cancer Centers - Central | Kansas City, Missouri 64111 |
