Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol
Médicament Data
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Maladies génito-urinaires+36
+ Maladies Génitales
+ Maladies Annexielles
Résumé
Date de début de l'étude : 1 mars 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated dose (MTD) of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors. Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients. Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients. Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients. Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population. OUTLINE: This is a dose-escalation, two-stage, multicenter study. During stage I, patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy. Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks. Patients continue courses of paclitaxel, dimesna, and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses. In stage I, cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose (MTD) is reached. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT). The MTD of dimesna is then used in stage II of the study, in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each. The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT. PROJECTED ACCRUAL: Approximately 35 patients will be accrued into this study.
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.2 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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 non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease No potentially curable type of cancer (e.g., newly diagnosed testicular cancer) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin normal SGOT and SGPT normal Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: No evidence of congestive heart failure No uncontrolled moderate to severe hypertension Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment Other: No active infection No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle No severe medical problems unrelated to malignancy that would interfere with compliance in this study Not pregnant Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors except for febrile neutropenia No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections No concurrent immunotherapy Chemotherapy: At least 6 weeks since prior nitrosoureas or mitomycin At least 3 weeks since other prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to measurable disease Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational agents
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 3 sites
University of Chicago Cancer Research Center
Chicago, United StatesOuvrir University of Chicago Cancer Research Center dans Google MapsSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesRoswell Park Cancer Institute
Buffalo, United States