Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more tumor cells by making the cells more sensitive to the drugs.

PURPOSE: Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer that has not been previously treated with chemotherapy.

Further Study Information

OBJECTIVES:

Primary

• Determine the overall survival of patients with chemotherapy-naïve advanced or recurrent non-small cell lung cancer treated with gemcitabine, carboplatin, and bortezomib.

Secondary

• Determine the response rate (confirmed and unconfirmed, complete and partial) and progression-free survival of patients with measurable disease treated with this regimen.

• Determine the quantitative toxic effects of this regimen in these patients.

• Correlate levels of hypoxia-induced secreted proteins and tumor DNA in plasma, levels of apoptosis-associated proteins in tumor tissue, and the change in levels of bortezomib-modulated proteins in peripheral white blood cells with response and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive bortezomib alone on the above schedule for up to 1 year at the discretion of the treating physician.

Patients are followed every 6 months for up to 3 years after registration.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study within 5 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• One of the following disease stages:

• Selected stage IIIB (T4 due to malignant pleural effusion, any N, M0)

• Stage IV (any T, any N, M1 [distant metastases present])

• Recurrent disease after prior surgery and/or radiotherapy

• Measurable or nonmeasurable disease by CT scan, MRI, or x-ray

• No pleural effusions, ascites, or laboratory parameters as the only evidence of disease

• Disease must be outside the prior radiation field or a new lesion formed inside the port

• No known brain metastases

• Must be offered participation in SWOG-S9925

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT or SGPT ≤ 2.5 times upper limit of normal

• Bilirubin normal

Renal

• Creatinine normal OR

• Creatinine clearance ≥ 60 mL/min

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known hypersensitivity to boron, mannitol, or bortezomib

• No greater than grade 1 peripheral neuropathy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic agents for NSCLC

• No concurrent biologic agents

Chemotherapy

• No prior systemic chemotherapy for NSCLC

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• At least 2 weeks since prior thoracic or other major surgery and recovered

Other

• No other concurrent anticancer agents

• No other concurrent investigational drugs

• No concurrent combination antiretroviral therapy for HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Angela Davies

Principal Investigator

Primo N. Lara

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00075751
Information obtained from ClinicalTrials.gov on December 14, 2011

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