Phase 2
Completed N=39
FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov NCT03283761 ↗Enrolled (actual)
39
Serious AEs
57.9%
Results posted
Feb 2024
Primary outcomePrimary: Objective Response Rate — 15 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
15 | — |
| SECONDARY Overall Survival (OS) |
10.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
6.6 | — |
| SECONDARY Time to Progression (TTP) |
11.26 | — |
| SECONDARY Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD |
1; 14; 13; 7; 3 | — |
| SECONDARY Disease Control Rate (DCR) |
80 | — |
| SECONDARY Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX |
38; 32; 32; 21 | — |
Eligibility Criteria
Inclusion Criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histologically-confirmed advanced or metastatic unresectable gastric carcinoma, or adenocarcinoma of the gastroesophageal junction.
- Prior neoadjuvant or adjuvant chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy must have been completed at least 6 months prior to documented recurrence or metastatic disease. NOTE: patients must not have received previous systemic treatment for metastatic disease.
- Evaluable disease according to RECIST v1.1 for solid tumors, within 28 days prior to registration.
- Demonstrate adequate organ function as described below; all screening labs to be obtained within 28 days prior to registration.
- Bilirubin 100, 000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample), Hemoglobin > 9.0g/dL and ANC > 1,500 cells/mm3.
- Patients must have adequate renal function: creatinine 3 years prior to registration with no clinical evidence of recurrence is permitted.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Data sourced from ClinicalTrials.gov (NCT03283761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.