Lung Cancer Clinical Trial
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
Full Description
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.
Eligibility 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)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 20 Locations for this study
Birmingham Alabama, 35233, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80010, United States
New Haven Connecticut, 06520, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Robbinsdale Minnesota, 55422, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Charlotte North Carolina, 28232, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Madison Wisconsin, 53792, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.