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Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00064012
Enrollment
4
Registered
2003-07-09
Start date
2003-05-31
Completion date
2004-07-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Brief 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.

Detailed 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.

Interventions

DRUGbortezomib
DRUGdocetaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026