Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
aminopterin
Maladies génito-urinaires+9
+ Maladies Génitales
+ Maladies urogénitales féminines et complications de la grossesse
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients. OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for 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.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.Femme
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 120 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 persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line chemotherapy Bidimensionally measurable disease by physical exam or medical imaging techniques (sonography acceptable if lesion(s) are clearly defined and measurable in two dimensions) Ascites and pleural effusions are not measurable PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: At least 4 weeks since any prior therapy directed at malignant endometrial tumor(s) At least 4 weeks since prior folate-containing vitamins No concurrent folate-containing vitamins No other concurrent anticancer therapy
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 6 sites
Division of Gynecologic Oncology
St Louis, United StatesOuvrir Division of Gynecologic Oncology dans Google MapsEast Carolina University School of Medicine
Greenville, United StatesGynecologic Oncologists of NE Ohio
Akron, United StatesSimmons Cancer Center - Dallas
Dallas, United States