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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

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.

Inclusion 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)

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068738

NCT ID:

NCT00021008

Start Date:

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Lung Neoplasms

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