Une étude sur le palifosfamide Tris plus la doxorubicine par rapport à la doxorubicine dans le sarcome des tissus mous non résécable ou métastatique (PICASSO)
Une étude multicentrique de phase II, à groupes parallèles et randomisée comparant le palifosfamide Tris plus la doxorubicine à la doxorubicine chez des sujets atteints de sarcome des tissus mous non résécable ou métastatique
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
-
Milan, Italie
-
Padova, Italie
-
Torino, Italie
-
-
-
-
-
Cluj-Napoca, Roumanie, 400015
-
Lasi, Roumanie
-
-
-
-
California
-
Santa Monica, California, États-Unis
-
-
District of Columbia
-
Washington D.C., District of Columbia, États-Unis
-
-
Florida
-
Tampa, Florida, États-Unis
-
-
Idaho
-
Coeur d'Alene, Idaho, États-Unis, 83814
-
-
Illinois
-
Chicago, Illinois, États-Unis
-
Park Ridge, Illinois, États-Unis
-
-
Iowa
-
Iowa City, Iowa, États-Unis
-
-
Kansas
-
Lenexa, Kansas, États-Unis
-
-
New Mexico
-
Albuquerque, New Mexico, États-Unis
-
-
New York
-
New York, New York, États-Unis
-
-
North Carolina
-
Durham, North Carolina, États-Unis
-
-
Oregon
-
Portland, Oregon, États-Unis
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis
-
-
Tennessee
-
Memphis, Tennessee, États-Unis
-
Nashville, Tennessee, États-Unis
-
-
Texas
-
San Antonio, Texas, États-Unis
-
-
Utah
-
Salt Lake City, Utah, États-Unis
-
-
Washington
-
Seattle, Washington, États-Unis
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
Age ≥18 years
-
Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.
-
Have measurable disease as per RECIST criteria (Appendix 2)
-
ECOG Performance Status of 0 or 1 (Appendix 3)
-
Anthracyclin naïve
-
Life expectancy of ≥12 weeks
-
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin ≤1.5×ULN (upper limit of normal)
- ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
- Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen). Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate.
- Serum creatinine ≤ULN
-
Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
-
Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial
-
Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment
Exclusion Criteria:
-
Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.
-
Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
-
Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)
-
History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
-
Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
-
History of HIV infection
-
Prior nephrectomy or history of urinary tract obstruction
-
Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
-
Any major surgery within 3 weeks prior to start of treatment
-
Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
-
Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies curatively treated >5 years prior to entry)
-
Pregnancy or lactation
-
Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
-
Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
In addition, use of the following therapies and medications-prior or concomitant-would exclude a subject from this study:
-
Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
-
Prior treatment with doxorubicin
-
Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)
-
Bone marrow transplant or stem cell rescue within 4 months of study entry
-
Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Palifosfamide-Tris Plus Doxorubicin
Participants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
Autres noms:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
Autres noms:
|
|
Comparateur actif: Doxorubicin Alone With Optional Palifosfamide-Tris After Progression
Participants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
Autres noms:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
L'analyse primaire d'efficacité sera menée sur la population en intention de traiter (ITT). Toutes les tentatives seront faites pour effectuer une évaluation de l'état de la maladie toutes les 6 semaines jusqu'à la progression de la maladie ou le lancement de thérapies anticancéreuses hors protocole.
Délai: Toutes les 6 semaines jusqu'à progression
|
Toutes les 6 semaines jusqu'à progression
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Jonathan J Lewis, MD, PhD, ZIOPHARM Oncology, Inc
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, tissus conjonctifs et mous
- Sarcome
- Produits chimiques organiques
- Hydrocarbures
- Hydrocarbures, cyclique
- Glucides
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Glycosides
- Anthracyclines
- Naphtacènes
- Aminoglycosides
- Daunorubicine
- Doxorubicine
- moutarde d'isophosphamide
- palifosfamide lysine
Autres numéros d'identification d'étude
- IPM2002
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .