- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00052507
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
Aperçu de l'étude
Description détaillée
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
- Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital at University Health Network
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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 or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy
- Metastatic or recurrent disease
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- Disease must be accessible to biopsy
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1 OR
- Karnofsky 70-100%
Life expectancy
- More than 3 months
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present)
Renal
- Creatinine no greater than 1.25 times UNL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No grade 1 or greater peripheral neuropathy due to prior chemotherapy
- No significant traumatic injury within the past 21 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior adjuvant chemotherapy allowed
- No concurrent cytotoxic chemotherapy
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy
- No concurrent radiotherapy to the sole site of measurable disease
Surgery
- More than 21 days since prior major surgery
Other
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Amit M. Oza, MD, Princess Margaret Hospital, Canada
Publications et liens utiles
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PMH-PHL-012
- CDR0000258488 (Identificateur de registre: PDQ (Physician Data Query))
- NCI-5890
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 .
Essais cliniques sur Cancer colorectal
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City of Hope Medical CenterRecrutementTumeurs colorectales | Cancer colorectal | Troubles colorectaux | Adénocarcinome colorectal | Cancer colorectal stade II | Cancer colorectal stade III | Cancer colorectal stade IV | Polype colorectal | Tumeurs colorectales malignes | Polype adénomateux colorectal | Cancer colorectal stade I | Adénome colorectal... et d'autres conditionsÉtats-Unis, Italie, Chine, Espagne, Japon
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University of California, San FranciscoComplétéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Docbot, Inc.RecrutementAdénome colorectal | Adénocarcinome colorectal | Polype colorectal | ASS colorectalÉtats-Unis
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University of Southern CaliforniaNational Cancer Institute (NCI)RésiliéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Actif, ne recrute pasCancer colorectal métastatique | Adénocarcinome colorectal | Cancer colorectal de stade IV | Cancer colorectal de stade IVA | Cancer colorectal de stade IVB | Carcinome colorectal réfractaire | Carcinome colorectal stable microsatellite métastatique | Cancer colorectal de stade IVCÉtats-Unis
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M.D. Anderson Cancer CenterRecrutementAdénocarcinome colorectal | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de... et d'autres conditionsÉtats-Unis
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RésiliéCancer rectal | Cancer du colon | Survivant du cancer | Adénocarcinome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal... et d'autres conditionsÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActif, ne recrute pasAdénome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade 0 AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal de stade II... et d'autres conditionsÉtats-Unis
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Roswell Park Cancer InstituteMerck Sharp & Dohme LLCRetiréAdénocarcinome colorectal métastatique | Adénocarcinome colorectal réfractaire | Microsatellite Stable | Cancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade... et d'autres conditionsÉtats-Unis
Essais cliniques sur bortézomib
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Columbia UniversityInconnueMésothéliomeÉtats-Unis
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Zhongnan HospitalRecrutementLeucémie myéloïde aiguë | BortézomibChine
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Fondazione Italiana Linfomi ONLUSComplétéMacroglobulinémie de WaldenströmItalie
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First Affiliated Hospital, Sun Yat-Sen UniversitySecond Affiliated Hospital of Guangzhou Medical UniversityInconnue
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King Faisal Specialist Hospital & Research CenterComplété