Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	WCCC-M34102-048 UCLA-0301037, MILLENNIUM-M34102-048, NCT00064012

Objectives

Primary

1. 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

1. Compare time to progression in patients treated with these regimens.
2. Compare the overall and 1-year survival of patients treated with these regimens.
3. Compare the safety and tolerability of these regimens in these patients.
4. Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
5. Compare the quality of life of patients treated with these regimens.

Entry 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

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)

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Platelet count greater than 100,000/mm³
• Hemoglobin greater than 8.0 g/dL
• Absolute neutrophil count greater than 1,500/mm³

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

Expected Enrollment

A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.

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.

Fanucchi MP, Fossella FV, Belt R, et al.: 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 24 (31): 5025-33, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Joan Schiller, MD, Principal investigator(Contact information may not be current)		Ph: 608-263-5389; 800-622-8922

Registry Information
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
Trial Start Date		2003-05-15
Registered in ClinicalTrials.gov		NCT00064012
Date Submitted to PDQ		2003-05-15
Information Last Verified		2004-05-18
NCI Grant/Contract Number		P30-CA16042

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