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

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: August 29, 2005
Last updated: February 7, 2011
Last verified: February 2011

August 29, 2005
February 7, 2011
January 2006
September 2008   (final data collection date for primary outcome measure)
Antitumor response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00138203 on Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
Suberoylanilide Hydroxamic Acid in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Non-Small Cell Lung Cancer

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.



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


  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
September 2008   (final data collection date for primary outcome measure)


  • 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



  • Over 18

Performance status

  • ECOG 0-1 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 3 months


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


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


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


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


  • 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


Biologic therapy

  • Not specified


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

Endocrine therapy

  • Not specified


  • 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


  • See Disease Characteristics


  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000439535, P30CA014520, WCCC-CO-04510, NCI-6860
Not Provided
Anne M. Traynor, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Anne M. Traynor, MD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP