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.

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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.

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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)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00064012

Recruitment Status:

Completed

Sponsor:

University of Wisconsin, Madison

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There are 20 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35233, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado, 80010, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
University of Miami Sylvester Cancer Center
Miami Florida, 33136, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
Kansas City Cancer Centers - Central
Kansas City Missouri, 64111, United States
Siteman Cancer Center
Saint Louis Missouri, 63110, United States
St. Louis University Hospital Cancer Center
Saint Louis Missouri, 63110, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00064012

Recruitment Status:

Completed

Sponsor:


University of Wisconsin, Madison

How clear is this clinincal trial information?

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