Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
Primary
- Compare the response rate in patients with "good risk" genotype (TSER*2/*2 or TSER*2/*3 genotype [low TS expression]) to historical control response rates in non-genotype selected patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels. The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen. Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed.
After completion of study treatment, patients are followed periodically for 4 years.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Tennessee
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Nashville, Tennessee, États-Unis, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, États-Unis, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, États-Unis, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
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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:
Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Metastatic disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
No known active brain metastases
- Patients with treated brain metastases are eligible if stable off steroids for at least 30 days
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)
- Creatinine clearance ≤ 1.5 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 21 days after completion of study treatment
- No history of allergic reactions to fluorouracil or oxaliplatin
- No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
No prior therapy for metastatic disease
- Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months
- No other concurrent chemotherapy
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No concurrent routine prophylaxis with filgrastim (G-CSF)
- No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Traitement
|
Collecte de sang
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
through a vein over 2 hours on days 1 and 15.
500 ml D5W through a vein over 2 hours on days 1 and 15.
Blood collection
Blood collection
Blood collection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Délai: every 8 weeks to progression
|
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
This is a one-time assessment.
|
every 8 weeks to progression
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
Publications et liens utiles
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
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de l'estomac
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents protecteurs
- Micronutriments
- Vitamines
- Hormones et agents régulateurs du calcium
- Antidotes
- Complexe de vitamine B
- Fluorouracile
- Oxaliplatine
- Leucovorine
- Calcium
- Lévoleucovorine
Autres numéros d'identification d'étude
- VICC GI 0716
- P30CA068485 (Subvention/contrat des NIH des États-Unis)
- VU-VICC-GI-0716
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