This is an open label, single-arm phase II, multi-institutional trial to evaluate the efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ adenocarcinoma.
All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Univeristy of Illinois Cancer Center
Chicago, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
University of Iowa Hospitals and Clinics
Objective Response Rate
Objective response rate will be calculated by combining the number of subjects who achieve complete response and partial response per RECIST 1.1 criteria.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm.
Time frame: From C1D1 until death or up to a maximum of 36 months
Overall Survival (OS)
Overall survival is defined by the date of the start of treatment to date of death from any cause.
Time frame: From C1D1 until death or up to a maximum of 52 months
Progression-Free Survival (PFS)
Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: From C1D1 until death or up to a maximum of 36 months
Time to Progression (TTP)
Time to progression is defined as the time from registration date until the criteria for disease progression per RECIST1.1 are met. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Iowa City, Iowa, United States
Michigan State University
Lansing, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Wisconsin
Madison, Wisconsin, United States
Time frame: From C1D1 until PD or up to a maximum of 36 months
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD
Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: From C1D1 until PD or up to a maximum of 36 months
Disease Control Rate (DCR)
The disease control rate is the proportion of all subjects with stable disease (SD) , or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From C1D1 until PD or up to a maximum of 36 months
Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX
Safety and tolerability of abemaciclib in the combination of nab-paclitaxel and FOLFOX in patients with metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma., assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: From C1D1 until death or up to a maximum of 52 months