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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00138203
First received: August 29, 2005
Last updated: February 7, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by University of Wisconsin, Madison:

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
Investigators
Study Chair: Anne M. Traynor, MD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
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: Anne M. Traynor, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00138203     History of Changes
Other Study ID Numbers: CDR0000439535, P30CA014520, WCCC-CO-04510, NCI-6860
Study First Received: August 29, 2005
Last Updated: February 7, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014