FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma
Status:
Terminated
Trial end date:
2020-10-29
Target enrollment:
Participant gender:
Summary
Background: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the
major causes of cancer-related death worldwide. In general, combination chemotherapy has been
associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine
doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan)
are some of the standard first-line regimens and are less toxic than the anthracycline
containing three drug regimen. Although platinum compounds are very effective in GE cancers,
patients who are treated with platinum-based therapy often develop severe neuropathy and may
not be able to tolerate a salvage second-line paclitaxel-based therapy.
Objectives: To evaluate progression free survival, time to progression, overall survival,
toxicity and quality of life in previously untreated patients with metastatic GE cancers who
will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating
with two cycles of FOLFIRI. To determine the correlation between various clinical and
pathological biomarkers including an early FDG-PET scan response and patient outcomes.
Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven
HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be
recruited at the two major cancer centers in Saskatchewan over a period of two years.
Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies
every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and
pathologic factors including an early FDG-PET/CT response and their correlation with patient
outcomes.
Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen
in the management of metastatic GE cancers, offering the possibility of longer disease
control as a result of 100% exposure to two active doublets in a first-line treatment setting
with lower neurotoxicities and an improved rate of salvage second-line therapy. This study
will inform the care of patients with metastatic GE cancers and will be used to design a
larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for
patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other
biomarkers in predicting outcomes.