Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
cisplatin
+ doxorubicin hydrochloride
+ tamoxifen citrate
Adénocarcinome+66
+ Adénocarcinome papillaire
+ Adénome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1994
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the feasibility and efficacy of cisplatin, doxorubicin, and tamoxifen (CAT) in patients with soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer. Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 14-30 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.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.Jusqu'à 65 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 proven soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer with clinical, radiological, or histologic evidence of incurability Patients with thyroid cancer must have failed radioactive iodine Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 65 and under Performance status: ECOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 140,000/mm3 Hepatic: Bilirubin normal Renal: Creatinine less than 1.47 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA scan No congestive heart failure No severe, uncontrolled hypertension No ischemia, life-threatening arrhythmia, or conduction disturbance by ECG Other: No allergy to study medications No uncontrolled infection No active abuse of ethanol that would preclude treatment No other prior or concurrent malignancy Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen No prior anthracycline or cisplatin At least 3 weeks since other prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to more than 25% of bone marrow At least 3 weeks since other prior radiotherapy and recovered Surgery: Not specified
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
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
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