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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064012
• Other study ID #: CDR0000305974
• Secondary ID: P30CA016042WCCC-
• Status: Completed
• Phase: Phase 2
• Start date: May 2003
• Est. completion date: July 2004

Study information

• Verified date: March 2013
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• bortezomib

• docetaxel

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Kansas City Cancer Centers - Central	Kansas City	Missouri
United States	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	St. Louis University Hospital Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone — View Citation