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

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064012

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: bortezomib Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Bortezomib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064012

Show 21 Study Locations

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Joan H. Schiller, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025-33.

Study ID Numbers:	CDR0000305974, WCCC-M34102-048, UCLA-0301037, MILLENNIUM-M34102-048
Study First Received:	July 8, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00064012 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Bortezomib

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Recurrence
Protease Inhibitors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Carcinoma

Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009