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- Registre américain des essais cliniques
- Essai clinique NCT00012194
7-hydroxystaurosporine and Cisplatin in Treating Patients With Advanced Malignant Solid Tumors
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of cisplatin in combination with UCN-01 in patients with advanced malignancies.
II. To assess the toxicity and observe the potential antitumor activity of UCN-01 plus cisplatin in advanced malignancies at each dose level studies.
III. To determine the pharmacokinetics of UCN-01 and cisplatin on this treatment schedule.
IV. To perform laboratory correlative studies to investigate intermediate molecular markers of the activity of UCN-01 and cisplatin at the cellular level.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2-3 months for at least 1 year.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Advanced or metastatic, histologcally/cytologically confirmed malignant solid tumor, not expected to clinically benefit from standard therapy
- Life expectancy greater than 3 months
- Previous chemotherapy and/or radiotherapy must have been completed at least four weeks (six weeks for prior treatment with mitomycin or nitrosoureas) and patients should have recovered from all toxicities of that therapy before treatment under this protocol
- All patients must have recovered from any surgical procedure
- Serum creatinine must be within the institutional limits of normal and an estimated creatinine clearance of >= 60 ml/min
- Normal bilirubin is required
- SGOT/AST must be less than or equal to 2.5 times the upper limit of institutional normal
- WBC >= 4000/mm^3
- Absolute neutrophil count >= 2000/mm^3
- Platelet count >= 150,000/mm^3
- Patients must have a Karnofsky Performance Status of 60% or greater
- Subjects who are fertile must use a medically acceptable contraceptive throughout the treatment period and for three months following cessation of treatment; subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children
- A signed informed consent (approved by the IRB) must be obtained prior to trial entry
- Tumor site accessible for both pre-treatment and post-treatment biopsy is preferred during dose-finding, and is required for patients entering the expanded cohort at the MTD
- All patients require a central indwelling venous catheter prior to treatment under this protocol
Exclusion Criteria:
- Peripheral neuropathy > grade I
- Any prior mediastinal radiotherapy
- Any history of coronary artery disease
- Class III or IV congestive heart failure according to the New York Heart Classification
- History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered in conjunction with protocol directed chemotherapy
- Brain metastasis
- Uncontrolled intercurrent illness that would preclude tolerance and completion of the protocol treatment, including vigorous hydration prior and subsequent to cisplatin therapy
- Lactating or pregnant women are excluded to avoid potential harm to the unborn child or infant; documentation of a negative, serum beta-HCG pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
- Receipt of any investigational drug within 30 days before beginning treatment with study drug
- Medical, social, or psychological factors that would prevent the patient from completing the treatment protocol
- Patients with clinically significant hearing loss
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treatment (7-hydroxystaurosporine, cisplatin)
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Études corrélatives
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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MTD of cisplatin defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing DLT attributable to the study drugs
Délai: 4 weeks
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Graded using the NCI CTCAE.
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4 weeks
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Toxicity observed at each dose level, graded using the NCI CTCAE
Délai: Up to 7 years
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Summarized in terms of type, severity, time of onset, duration, and reversibility or outcome.
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Up to 7 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective tumor response
Délai: Up to 7 years
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Summarized at each dose level, and the number and percent responding combined across dose levels.
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Up to 7 years
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Overall survival
Délai: From registration to time of death due to any cause, assessed up to 7 years
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Summarized with Kaplan-Meier plots.
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From registration to time of death due to any cause, assessed up to 7 years
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Time to treatment failure
Délai: From registration to the first observation of disease progression, death due to any cause, or early discontinuation of treatment, assessed up to 7 years
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Summarized with Kaplan-Meier plots.
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From registration to the first observation of disease progression, death due to any cause, or early discontinuation of treatment, assessed up to 7 years
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Duration of response
Délai: Up to 7 years
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Summarized with Kaplan-Meier plots.
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Up to 7 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Raymond Perez, Dartmouth-Hitchcock Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCI-2012-03129
- DMS 9934
- DMS-9934
- NCI-2331
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