A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
triapine
+ cisplatin
+ laboratory biomarker analysis
Carcinome épithélial ovarien+19
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2005
Date à laquelle le premier participant a commencé l'étude.PRIMARY OBJECTIVES: I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer. II. Determine the toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival in patients treated with this regimen. II. Determine the effects of prognostic variables, including initial performance status, age, and mucinous (or clear cell) histology, in these patients. OUTLINE: This is a non-randomized study. Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13 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.48 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.Femme
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
Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Outside a previously irradiated field * Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease * Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment * Considered platinum resistant or refractory, according to 1 of the following criteria: * Treatment-free interval of less than 6 months after platinum-based therapy * Disease progression during platinum-based therapy * Ineligible for any higher priority GOG protocol * Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen) * Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens) * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN * No serious cardiac disease * No prior myocardial infarction * No uncontrolled congestive heart failure * No pulmonary disease requiring oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neuropathy (sensory and motor) ≤ grade 1 * No active infections requiring antibiotics * No hearing impairment * No known G6PD deficiency * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * At least 3 weeks since prior biologic or immunologic agents for malignant tumor * One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed * See Disease Characteristics * One prior paclitaxel-containing regimen allowed * No prior 3-AP * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens * Recovered from prior chemotherapy * At least 1 week since prior hormonal therapy for malignant tumor * Concurrent hormone replacement therapy allowed * No prior radiotherapy to more than 25% of marrow-bearing areas * Recovered from prior radiotherapy * Recovered from prior surgery * No prior cancer therapy that contraindicates receiving study therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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