RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ABT-751 in treating patients who have stage IIIB or stage IV non-small cell lung cancer that is refractory to taxane therapy (such as paclitaxel or docetaxel).

Condition	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer	Drug: ABT-751  Procedure: chemotherapy	Phase II

OBJECTIVES: Primary

• Determine the objective response rate (partial and complete responses) in patients with stage IIIB or IV non-small cell lung cancer refractory to taxane therapy when treated with ABT-751.

Secondary

• Determine the time to progression in patients treated with this drug.
• Determine the survival of patients treated with this drug.
• Determine the duration of overall response in patients treated with this drug.
• Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral ABT-751 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer
• Stage IIIB or IV disease
• Refractory to at least 2 courses (6 weeks) of prior taxane therapy (e.g., paclitaxel or docetaxel)
• Disease progression during or within 9 weeks of completing taxane therapy in the adjuvant setting OR during or within 24 weeks of completing taxane therapy in the metastatic setting
• Measurable disease
• No known CNS metastasis

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,200/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Bilirubin ≤ 2 mg/dL (3.0 mg/dL if liver metastases are present)

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

• No unstable cardiovascular conditions
• No uncontrolled hypertension
• No angina
• No New York Heart Association class III congestive heart failure within the past 6 months
• No myocardial infarction within the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation
• No neurology category findings greater than grade 1 (e.g., paresthesia, deep tendon reflexes, or weakness that is subjective and/or does not interfere with function)
• No allergy to sulfa medications
• No other clinically significant medical condition that would preclude study participation
• No other prior or concurrent malignancies except for the following:
• Adequately treated carcinoma in situ of the cervix
• Basal cell or squamous cell skin cancer
• Prior nonpulmonary malignancy confined and surgically resected with no evidence of disease within the past 3 years

PRIOR CONCURRENT THERAPY: Biologic therapy

• No hematopoietic growth factors given concurrently with study drug

Chemotherapy

• See Disease Characteristics
• No more than 2 prior chemotherapy regimens

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy

Surgery

• More than 6 months since prior coronary angioplasty or stenting
• No concurrent surgery

Other

• More than 4 weeks since prior antitumor therapy
• No more than 1 prior investigational agent given alone or with standard taxane therapy
• No concurrent colchicine
• No other concurrent investigational agents
• No other concurrent anticancer therapy

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-5907,  United States; Recruiting

Study chairs or principal investigators

Robert Alan Figlin, MD, FACP,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000355130; UCLA-0308111; ABBOTT-M02-448
Record last reviewed:  February 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080730
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29