- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00029003
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.
II. To assess the progression-free survival and overall survival in these groups of patients.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.
V. To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.
VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Texas
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San Antonio, Texas, États-Unis, 78245
- Southwest Oncology Group
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients must have a biopsy-proven, incompletely resected or unresectable bronchioloalveolar carcinoma, with pathology tissue available for central review and staining for EGFR and other molecular variables; fine needle aspirates, bronchial brushings or washings are not permitted for diagnosis; patients must have either selected stage IIIB due to cytology-confirmed malignant pleural effusion, or stage IV disease; tumors may be multi-focal or diffuse
- Patients must have evidence of disease by CT scan of the chest; the pre-study CT scan of the chest must include the liver and adrenal glands or be accompanied by an abdominal CT scan in which they are visualized; all x-rays/scans to assess measurable disease must have performed within 28 days prior to registration; all other required tests to assess non-measurable disease must have been performed within 42 days prior to registration
- The institution must plan to submit all pathology materials (i.e., H&E stained slide from each block, plus 10 unstained slide from one block) within 30 days after registration
- All patients must have a Zubrod performance status of 0-2
Patients must not have received prior treatment with biologic therapies that target EGFR; patients may not be currently receiving or planning to receive any other treatment directed at the BAC
- Prior biologic therapy, chemotherapy and radiotherapy are allowed, provided that at least four weeks have elapsed since last treatment with these modalities and the patient's disease has been assessed since completing previous treatment; disease must be present outside of areas of previous radiation therapy
- Prior surgery is allowed, provided that the patient has had sufficient recovery time from surgery, as determined by the enrolling physician
- Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation; patients must not have had prior surgical procedures affecting absorption
- Serum bilirubin =< 1.5 x the institutional upper limit of normal
- SGOT or SGPT =< 2.5 x the institutional upper limit of normal (IULN) (if liver metastases are present; SGOT/SGPT =< 5 IULN allowed)
- Alkaline phosphatase =< 2.5 x IULN (if bone metastases are present, alkaline phosphatase =< 5 x IULN is allowed); abnormalities in alkaline phosphatase levels should be appropriately followed to document the possibility of bone or hepatic metastases
- ANC >= 1,500/uL
- WBC >= 3,000/uL
- Platelet count >= 100,000/uL
- Institution must have receive IRB approval for S9925; patients must be offered participating in S9925 (the Lung Cancer Specimen Repository); optional submissions of buccal brushings for EGFR determination will be done via the Lung Cancer Specimen Repository; patients must be registered separately to S9925 to receive credit for buccal brushing submission
- Patient with known brain metastases are ineligible for this clinical trial; if there are any abnormal findings on neurological examination suspicious for brain metastases, a CT or MRI should be performed within 42 days prior to registration
- NOTE: a baseline slit lamp examination is NOT required; however, patients with eye symptoms (eye pain, tearing, redness, vision problems) should be evaluated by an ophthalmologist/optometrist prior to registration and the results documented on the S0126 Toxicity and Dosage Form
- Patient must not have corneal inflammation or infection
- Patients requiring agents that induce CYP3A4 are excluded from the study, due to the ability of these agents to significantly reduce plasma concentrations of ZD1839 potentially below the range likely to be biologically active if taken concurrently with ZD1839 at the dose employed in the study; at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, and phenytoin, as well as St. John's wort
- Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
- No other prior malignancy is allowed except to the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
- Pregnant or nursing women are not eligible to participate in this trial; women/men of reproductive potential must have agreed to use an effective contraceptive method
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
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 (gefitinib)
Patients receive oral gefitinib once daily.
Treatment continues in the absence of disease progression or unacceptable toxicity.
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Études corrélatives
Donné oralement
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Overall survival rate
Délai: Up to 1 year
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Up to 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Progression-free survival
Délai: From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years
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From the date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 2 years
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Change in EGFR and EGFR variant III overexpression and their relationship with survival
Délai: From baseline to up to 1 year
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From baseline to up to 1 year
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Response via CAIA versus response by RECIST
Délai: At 16 weeks
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At 16 weeks
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Toxicity as assessed by CTCAE version 3.0
Délai: Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Howard West, Southwest Oncology Group
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
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Adénocarcinome
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Adénocarcinome du poumon
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Adénocarcinome bronchiolo-alvéolaire
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de protéine kinase
- Géfitinib
Autres numéros d'identification d'étude
- NCI-2012-03073
- U10CA032102 (Subvention/contrat des NIH des États-Unis)
- S0126
- CDR0000069157 (Identificateur de registre: PDQ (Physician Data Query))
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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