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

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075751

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: bortezomib Drug: carboplatin Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride Bortezomib

U.S. FDA Resources

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

Study Start Date:

January 2004

Detailed Description:

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

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 (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075751

Show 90 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Angela Davies, MD	University of California, Davis
Investigator:	Primo N. Lara, MD	University of California, Davis

More Information

Additional Information:

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

Publications:

Davies AM, Chansky K, Lara PN Jr, Gumerlock PH, Crowley J, Albain KS, Vogel SJ, Gandara DR; Southwest Oncology Group. Bortezomib plus gemcitabine/carboplatin as first-line treatment of advanced non-small cell lung cancer: a phase II Southwest Oncology Group Study (S0339). J Thorac Oncol. 2009 Jan;4(1):87-92.

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.

Study ID Numbers:	CDR0000349336, SWOG-S0339
Study First Received:	January 9, 2004
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00075751 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:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Bortezomib
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Recurrence
Protease Inhibitors

Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Bortezomib
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009