A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
Collecte de données
Néoplasmes pulmonaires+4
+ Maladies pulmonaires
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 2002
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer. * Determine the qualitative and quantitative toxic effects of this drug in these patients. Secondary * Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug. * Determine the patterns of failure and survival in patients treated with this drug. OUTLINE: This is a pilot study. Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy beyond CR. Patients achieving CR due to local consolidative therapy (surgery or radiotherapy) receive 2 additional courses of therapy beyond CR. Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-18 months.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.30 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC), meeting criteria for 1 of the following: * Locally advanced disease not amenable to radiotherapy or surgery * Metastatic disease * Received at least 1 course of platinum-based (e.g., cisplatin or carboplatin) chemotherapy * No uncontrolled central nervous system (CNS) metastases * Ineligible for higher priority treatment protocols PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-1 OR * Zubrod Scale 0-1 OR * South West Oncology Group (SWOG) 0-1 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times normal * Serum glutamate oxaloacetate transaminase (SGOT) and Serum glutamate pyruvate transaminase (SGPT) no greater than 3 times normal Renal * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 12 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No uncontrolled, clinically significant dysrhythmia * Cardiac ejection fraction greater than 50% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Electrolytes (including magnesium) normal * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No prior or ongoing peripheral neuropathy grade 2 or greater * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent cytokine therapy Chemotherapy * See Disease Characteristics * No more than 2 prior chemotherapy regimens for NSCLC * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion * No concurrent radiotherapy * Concurrent palliative or emergent radiotherapy allowed Surgery * More than 2 weeks since prior surgery Other * At least 4 weeks since prior antineoplastic agents for non-malignant conditions (e.g., methotrexate for rheumatoid arthritis) * No concurrent antineoplastic agents for non-malignant conditions
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site