Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer - Full Text View

Sponsor:	University of Wisconsin, Madison
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00138203

Purpose

RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: vorinostat	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

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

Primary Outcome Measures:

Antitumor response rate as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression and overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	23
Study Start Date:	January 2006
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the response in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with suberoylanilide hydroxamic acid.

Secondary

Determine the time to progression and overall survival of patients treated with this drug.
Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study within 11-18 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, meeting 1 of the following criteria:
- Stage IV disease
- Stage IIIB disease with malignant pleural effusion
- Recurrent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Previously treated with 1, and only 1, cytotoxic chemotherapy regimen for Stage IIIB or IV or recurrent disease
Brain metastases allowed provided they are clinically and radiologically stable for 4 weeks after treatment with surgery and/or radiotherapy AND there is no requirement for steroids

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

ECOG 0-1 OR
Karnofsky 70-100%

Life expectancy

More than 3 months

Hematopoietic

WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal

Renal

Creatinine normal OR
Creatinine clearance ≥ 60 mL/min

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
No peripheral neuropathy > grade 1
No other active malignancy within the past 5 years except nonmelanoma skin cancer
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No history of allergic reaction attributed to compounds of similar chemical or biological composition of study drug
No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 3 weeks since prior radiotherapy
No prior radiotherapy to the only site of measurable disease unless there is subsequent disease progression

Surgery

See Disease Characteristics

Other

At least 2 weeks since prior valproic acid
No other concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138203

Locations

United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Study Chair:

Anne M. Traynor, 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:

Traynor AM, Dubey S, Eickhoff JC, Kolesar JM, Schell K, Huie MS, Groteluschen DL, Marcotte SM, Hallahan CM, Weeks HR, Wilding G, Espinoza-Delgado I, Schiller JH. Vorinostat (NSC# 701852) in patients with relapsed non-small cell lung cancer: a Wisconsin Oncology Network phase II study. J Thorac Oncol. 2009 Apr;4(4):522-6.

Traynor AM, Dubey S, Eickhoff J, et al.: Vorinostat (NSC 701852) in patients (pts) with relapsed non-small cell lung cancer (NSCLC): a Wisconsin Oncology Network phase II study. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B94, 2007.

Responsible Party:	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( Anne M. Traynor )
Study ID Numbers:	CDR0000439535, WCCC-CO-04510, NCI-6860
Study First Received:	August 29, 2005
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00138203 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

Additional relevant MeSH terms:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 09, 2010