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

Alternate Title

Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 18 NCI SWOG-S0339 S0339, NCT00075751

Objectives

Primary

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

Secondary

1. Determine the response rate (confirmed and unconfirmed, complete and partial) and progression-free survival of patients with measurable disease treated with this regimen.
2. Determine the quantitative toxic effects of this regimen in these patients.
3. 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.

Entry 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

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

Patient Characteristics:

Age

• Over 18

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

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.

Davies AM, McCoy J, Lara PN, et al.: Bortezomib + gemcitabine (Gem)/carboplatin (Carbo) results in encouraging survival in advanced non-small cell lung cancer (NSCLC): results of a phase II Southwest Oncology Group (SWOG) trial (S0339). [Abstract] J Clin Oncol 24 (Suppl 18): A-7017, 368s, 2006.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Angela Davies, MD, Study coordinator		Ph: 916-734-3771
Primo Lara, MD, Study coordinator		Ph: 916-734-3771

Registry Information
Official Title		A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Trial Start Date		2004-01-15
Registered in ClinicalTrials.gov		NCT00075751
Date Submitted to PDQ		2003-12-04
Information Last Verified		2004-08-16
NCI Grant/Contract Number		CA32102

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