- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00126542
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erlotinib.
SECONDARY OBJECTIVES:
I. Determine the toxic effects of this regimen in these patients. II. Determine the median progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
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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:
Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- Recurrent or metastatic disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have received a platinum-containing chemotherapy regimen for primary disease
Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum
- Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease
- No evidence of CNS disease, including primary brain tumors or brain metastasis
- Performance status - ECOG 0-2
- More than 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No history of bleeding diathesis
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
- Bilirubin normal
- INR ≤ 1.5 (3 if receiving warfarin)
- No history of esophageal varices
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 60 mL/min
- Urine protein < 1+
- Urine protein < 1,000 mg on 24-hour urine collection
- Urine protein:creatinine ratio < 1.0
No arterial thromboembolic event within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina pectoris
- Myocardial infarction
- No clinically significant peripheral artery disease
- No uncontrolled hypertension
- No New York Heart Association grade II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No peripheral vascular disease ≥ grade 2
- Not pregnant
- No nursing during and for ≥ 3 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after study participation
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
- No serious or non-healing wound, ulcer, or bone fracture
- No active infection requiring parenteral antibiotics
- No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No gastrointestinal tract disease resulting in an inability to take oral medication
- No significant traumatic injury within the past 28 days
- No known HIV positivity
- No prior bevacizumab
- See Disease Characteristics
- No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy)
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy
- More than 4 weeks since prior major surgical procedure or open biopsy
- More than 1 week since prior core biopsy
- No prior surgery affecting absorption
- No concurrent major surgery
- Recovered from prior therapy
- No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy
- No prior erlotinib
- At least 30 days since prior investigational drugs
- More than 1 month since prior thrombolytic agents
Concurrent warfarin allowed provided the following criteria are met:
- Patient is on a therapeutic stable dose of warfarin
- INR ≤ 3
- No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
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 |
---|---|
Expérimental: Treatment (bevacizumab, erlotinib hydrochloride)
Patients receive bevacizumab IV over 30-90 minutes on day 1.
Patients also receive oral erlotinib once daily on days 1-21.
Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.
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Études corrélatives
Étant donné IV
Autres noms:
Donné oralement
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Response rate of patients treated with the combination of bevacizumab and OSI-774
Délai: Up to 5 years
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Up to 5 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free survival
Délai: Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
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Will be analyzed using the Kaplan-Meier estimator (Kaplan 1958), and median progression-free survival times and their associated 90% confidence intervals will be determined using the method described in Brookmeyer and Crowley (Brookmeyer 1982).
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Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years
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Median progression-free survival
Délai: From start of treatment to time of progression, assessed up to 5 years
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Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
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From start of treatment to time of progression, assessed up to 5 years
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Overall survival
Délai: Up to 5 years
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Overall survival rates and median overall survival times and their associated 90% confidence intervals will be determined by the same methods.
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Up to 5 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gini Fleming, University of Chicago
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (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
- Maladies du système digestif
- Processus pathologiques
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Maladies péritonéales
- Tumeurs génitales, femme
- Maladies du système endocrinien
- Attributs de la maladie
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Tumeurs du système digestif
- Tumeurs des glandes endocrines
- Maladies des trompes de Fallope
- Tumeurs abdominales
- Tumeurs ovariennes
- Récurrence
- Tumeurs des trompes de Fallope
- Tumeurs péritonéales
- Carcinome épithélial ovarien
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Facteurs immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Inhibiteurs de protéine kinase
- Anticorps
- Chlorhydrate d'erlotinib
- Immunoglobulines
- Bévacizumab
- Anticorps monoclonaux
- Agents antinéoplasiques immunologiques
Autres numéros d'identification d'étude
- NCI-2012-02660 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Subvention/contrat des NIH des États-Unis)
- N01CM62203 (Subvention/contrat des NIH des États-Unis)
- P30CA014599 (Subvention/contrat des NIH des États-Unis)
- N01CM62209 (Subvention/contrat des NIH des États-Unis)
- UCCRC-13576A
- NCI-6759
- CDR0000434820
- 13576A (Autre identifiant: University of Chicago)
- 6759 (Autre identifiant: CTEP)
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 .
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