A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
carboplatin
+ cisplatin
+ gemcitabine hydrochloride
Néoplasmes bronchiques+7
+ Carcinome bronchogénique
+ Maladies pulmonaires
Étude thérapeutique
Résumé
OBJECTIVES: I. Determine the response rates of gemcitabine and carboplatin vs gemcitabine and cisplatin in patients with stage IIIB, IV, or recurrent non-small cell lung cancer. II. Determine the toxicity of these two regimens in this patient population. III. Determine the time to progression and one year survival of these patients on these regimens. OUTLINE: This is a randomized study. Patients are stratified by stage of disease and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by carboplatin over 60 minutes on day 1. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by cisplatin IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every two months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 1 year.
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.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 or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) Recurrent NSCLC treated with radiation or surgery allowed Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam outside of irradiation field No active CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hematocrit at least 30% Hepatic: Bilirubin no greater than 2 mg/dL PT or aPTT no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No serious concurrent systemic disorder that would preclude study compliance No active infection No second primary malignancy within the past 5 years, except: Adequately treated basal cell skin cancer Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent hormonal therapy (except contraceptives and replacement steroids) Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior investigational drugs No other concurrent experimental drugs No concurrent interleukin-11 for patients with cardiac disease