Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
OBJECTIVES:
I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.
II. Determine the duration of remission and survival of patients treated with this drug.
III. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.
Inclusion Criteria:
Diagnosis of small cell lung cancer (SCLC)
At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Sensitive* relapsed disease after only 1 prior chemotherapy regimen
Brain metastasis allowed provided the following criteria are met:
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
At least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
Bilirubin ≤ 1.5 mg/dL
Creatinine < 2.0 mg/dL
Creatinine clearance ≥ 60 mL/min
No New York Heart Association class III or IV heart disease
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active or ongoing infection
No other concurrent uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance
See Disease Characteristics
See Disease Characteristics
See Disease Characteristics
Prior radiotherapy allowed
No other concurrent investigational agents
No other concurrent therapies for SCLC
No concurrent combination antiretroviral therapy for HIV-positive patients