RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer Quality of Life	Drug: ZD0473	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy. II. Assess the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in terms of time to death, time to disease progression, disease control, and duration of response, in these patients. V. Assess the therapy outcome index, in terms of disease-related symptom relief, of these patients treated with this drug.

PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy (12 weeks or less vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after study completion and every 6 weeks for 1 year.

PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2) will be accrued for this study within approximately 9 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed non-small cell lung cancer; Progressive or relapsed disease after first-line platinum-based chemotherapy
• Measurable disease
• No intracerebral metastases (unless asymptomatic, no corticosteroids required, and diagnostic imaging demonstrates no peritumoral edema or progression)

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: No prior extensive radiotherapy to 30% or more of bone marrow (e.g., whole of pelvis or half of spine)
• Surgery: Recovered from prior surgery
• Other: At least 2 weeks since prior systemic anticancer therapy and recovered

--Patient Characteristics--

• Age: 18 and over
• Performance status: WHO 0-2
• Life expectancy: More than 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
• Hepatic: Bilirubin no greater than 1.25 times the upper limit of normal (ULN); ALT or AST less than 2.5 times ULN (5 times ULN if liver metastases present); No hepatic impairment; No risk of hepatitis B transmission
• Renal: Creatinine clearance at least 60 mL/min
• Cardiovascular: No currently unstable or uncompensated cardiac conditions
• Pulmonary: No currently unstable or uncompensated respiratory conditions
• Other: No risk of HIV transmission; No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix; No other severe or uncontrolled systemic disease; No infectious condition; No significant clinical disorder that would preclude study; Body surface area at least 1.2 m2; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception for 3 months before, during, and for 3 months after study

Study chairs or principal investigators

Robert Alan Figlin,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068738; UCLA-000307201A; NCI-G01-1974; ZENECA-0473IL/0003
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021008
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08