Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
becatecarin
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location