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

Condition(s) targeted: Lung Cancer

Intervention: vorinostat (Drug); chemotherapy (Procedure); enzyme inhibitor therapy (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Anne M. Traynor, MD, Study Chair, Affiliation: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

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.

Official title: A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Non-Small Cell Lung Cancer

Study design: Treatment, Open Label

Primary outcome: Antitumor response rate as assessed by RECIST criteria

Secondary outcome:

Time to progression and overall survival

Progression-free survival

Toxicity

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States; Recruiting
Clinical Trials Office - University of Wisconsin Paul P. Carbo, Phone: 608-262-5223

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2006
Last updated: December 25, 2007