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This Phase 1 trial by the National Cancer Institute (NCI) studied the effectiveness of combination chemotherapy plus oblimersen sodium (augmerosen, G3139, a bcl-2 antisense oligodeoxynucleotide, Genasense) in patients with extensive-stage small cell lung cancer. Oblimersen may make tumor cells more sensitive to chemotherapy and was given with carboplatin and etoposide, alongside pharmacological studies and laboratory biomarker analysis. Eligible patients had histologically or cytologically confirmed extensive-stage disease with no active central nervous system involvement; the trial is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically or cytologically confirmed extensive stage small cell lungcancer * No active CNS disease * CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 2 months * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * PT and PTT no greater than 1.5 times ULN * Creatinine normal * Creatinine clearance at least 60 mL/min * 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 prior allergic reactions to compounds of similar chemical or biologic composition to study agents * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * See Disease Characteristics * At least 1 week since prior CNS radiotherapy and recovered * No prior radiotherapy to more than 25% of skeleton * No other prior anticancer therapy * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent anticoagulation therapy * No concurrent combination antiretroviral therapy for HIV-positive patients