- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00004879
Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
- Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
- Evaluate the clinical effect of this drug in this patient population.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.
NOTE: *All patients receive a total of 4 doses.
Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.
Patients are followed every 2 weeks for 5 weeks.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095-1738
- Jonsson Comprehensive Cancer Center, UCLA
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer 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
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Renal cell cancer (RCC)
- Prior nephrectomy required
Prostate cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
Pancreatic cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
Non-small cell lung cancer
- Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
Colorectal cancer
- Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
Esophageal cancer
- Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
- Gastroesophageal junction cancer
- Evaluable disease
Epidermal growth factor receptor overexpression
- Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
- No uncontrolled brain metastases
- No evidence of disease progression or regression after a 30-day washout period
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100% OR
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
- Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)
Renal:
- Creatinine less than 2.2 mg/dL
- NCI renal toxicity no greater than grade 2
- No hypercalcemia (antihypercalcemic therapy allowed)
Cardiovascular:
- Ejection fraction at least 45% by MUGA
- No abnormal ECG or MUGA
- No myocardial infarction within the past year
Pulmonary:
- No abnormal chest x-ray
- FEV_1 greater than 50% of predicted
Other:
- No known allergy to ingredients of study drug
- No known allergy to Staphylococcus aureus Protein A
- HIV negative
- No chronic medical or psychiatric condition that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
- No other concurrent biologic therapy
Chemotherapy:
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy and recovered
- No prior chemotherapy for RCC
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- Concurrent steroids allowed
- Concurrent hormonal therapy allowed
Radiotherapy:
- See Disease Characteristics
- No prior mediastinal radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any recent prior surgery
Other:
- At least 30 days since prior investigational drug or device
- At least 30 days since prior systemic therapy
- No other concurrent investigational drugs
- No other concurrent systemic agents or cancer therapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude
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
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs urologiques
- Tumeurs urogénitales
- Tumeurs par site
- Maladies rénales
- Maladies urologiques
- Maladies du système endocrinien
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Tumeurs des glandes endocrines
- Tumeurs génitales, homme
- Maladies de la prostate
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Maladies pancréatiques
- Tumeurs rénales
- Tumeurs prostatiques
- Tumeurs pancréatiques
- Tumeurs de l'oesophage
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Panitumumab
Autres numéros d'identification d'étude
- CDR0000067539
- UCLA-9906078
- ABX-EG-9901
- UCLA-9906078-04B
- NCI-G00-1673
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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