Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI, Other	CDR0000439535 WCCC-CO-04510, NCI-6860, NCT00138203

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Anne M. Traynor

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00138203
Information obtained from ClinicalTrials.gov on December 17, 2009

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