MOMENTUM: A Phase I Trial Investigating 2 Schedules of Capecitabine With Aflibercept in Patients With Gastrointestinal and Breast Cancer.
Adult
Aged
Anorexia
/ chemically induced
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Breast Neoplasms
/ drug therapy
Capecitabine
/ administration & dosage
Colorectal Neoplasms
/ drug therapy
Dose-Response Relationship, Drug
Drug Resistance, Neoplasm
Feasibility Studies
Female
Hand-Foot Syndrome
/ diagnosis
Humans
Hypertension
/ chemically induced
Male
Maximum Tolerated Dose
Middle Aged
Receptors, Vascular Endothelial Growth Factor
/ administration & dosage
Recombinant Fusion Proteins
/ administration & dosage
Response Evaluation Criteria in Solid Tumors
Severity of Illness Index
Stomach Neoplasms
/ drug therapy
Anti-angiogenic therapy
Colorectal cancer
Fluoropyrimidine
Metronomic chemotherapy
gastric cancer
Journal
Clinical colorectal cancer
ISSN: 1938-0674
Titre abrégé: Clin Colorectal Cancer
Pays: United States
ID NLM: 101120693
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
23
03
2020
revised:
16
05
2020
accepted:
22
05
2020
pubmed:
8
7
2020
medline:
23
11
2021
entrez:
8
7
2020
Statut:
ppublish
Résumé
Although data from preclinical and clinical studies provide a strong rationale for combining capecitabine with anti-angiogenic agents, clinical development of this fluoropyrimidine in combination with aflibercept has lagged behind other treatments. We conducted a nonrandomized, noncomparative, 2-arm, phase I trial to address this unmet need. Patients with chemorefractory gastrointestinal and breast cancer were sequentially recruited into a continuous (Arm A, starting dose 1100 mg/m Thirty-eight eligible patients were recruited of whom 33 were assessable for DLTs (15 in arm A and 18 in arm B). Fourteen had colorectal cancer, 8 gastric cancer, and 11 breast cancer. DLTs included grade 2 hand-foot syndrome, grade 2 anorexia considered unacceptable by the patient, and grade 3 hypertension. The recommended dose for phase II trials for capecitabine was established at 1300 mg/m Combining capecitabine with aflibercept is feasible and associated with a manageable safety profile and some anti-tumor activity in patients with chemorefractory gastrointestinal and breast cancer.
Sections du résumé
BACKGROUND
Although data from preclinical and clinical studies provide a strong rationale for combining capecitabine with anti-angiogenic agents, clinical development of this fluoropyrimidine in combination with aflibercept has lagged behind other treatments. We conducted a nonrandomized, noncomparative, 2-arm, phase I trial to address this unmet need.
PATIENTS AND METHODS
Patients with chemorefractory gastrointestinal and breast cancer were sequentially recruited into a continuous (Arm A, starting dose 1100 mg/m
RESULTS
Thirty-eight eligible patients were recruited of whom 33 were assessable for DLTs (15 in arm A and 18 in arm B). Fourteen had colorectal cancer, 8 gastric cancer, and 11 breast cancer. DLTs included grade 2 hand-foot syndrome, grade 2 anorexia considered unacceptable by the patient, and grade 3 hypertension. The recommended dose for phase II trials for capecitabine was established at 1300 mg/m
CONCLUSION
Combining capecitabine with aflibercept is feasible and associated with a manageable safety profile and some anti-tumor activity in patients with chemorefractory gastrointestinal and breast cancer.
Identifiants
pubmed: 32631787
pii: S1533-0028(20)30080-3
doi: 10.1016/j.clcc.2020.05.007
pii:
doi:
Substances chimiques
Recombinant Fusion Proteins
0
aflibercept
15C2VL427D
Capecitabine
6804DJ8Z9U
Receptors, Vascular Endothelial Growth Factor
EC 2.7.10.1
Banques de données
ClinicalTrials.gov
['NCT01843725']
EudraCT
['2012-005169-11']
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
311-318.e1Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.