Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI UCLA-000307201A ZENECA-0473IL/0003, NCI-G01-1974, NCT00021008

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.

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

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Robert Figlin, MD, FACP, Protocol chair(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719

Registry Information
Official Title		A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients with Non-Small Lung Cancer Who have Failed One Prior Platinum Based Chemotherapy Regimen
Registered in ClinicalTrials.gov		NCT00021008
Date Submitted to PDQ		2001-05-11
Information Last Verified		2001-09-01
NCI Grant/Contract Number		P30-CA16042