Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
18 Years
N/A
Both
Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
Trial Information
Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
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)
- Limited or extensive stage
- 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:
- Stable brain disease
- Not receiving irradiation
- No steroid requirement to control symptoms
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate estimated as the proportion of responders
Outcome Description:
An exact binomial 95% confidence interval will be calculated for this proportion.
Outcome Time Frame:
Up to 4 years
Safety Issue:
No
Principal Investigator
Afshin Dowlati
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Western Reserve University
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02587
NCT ID:
NCT00084487
Start Date:
April 2004
Completion Date:
Related Keywords:
- Extensive Stage Small Cell Lung Cancer
- Limited Stage Small Cell Lung Cancer
- Recurrent Small Cell Lung Cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Case Western Reserve University | Cleveland, Ohio 44106 |
