mFLOT Chemotherapy as First-line Treatment in GC

NCT03606928 | Completed Phase 1 DMC

• 1 other identifier: mFLOT-GC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A single center phase 1b/2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients. This trial is designed to identified recommended phase II dose (RP2D) of modified FLOT in Chinese patients, and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer. This trial is in 2 stages: the first stage will establish the maximum tolerated dose (MTD) and RP2D of docetaxel and oxaliplatin in FLOT regime. In the second stage, the efficacy of modified FLOT will be assessed by response rate.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose and recommended phase II dose of modified FLOT regime

  36 months

• Objective response rate

  36 months

Secondary Outcomes (3)

• Overall survival

  36 months

• Progression free survival

  36 months

• Safety: adverse events as assessed by CTCAE v4.0

  36 months

Study Arms (1)

modified FLOT

EXPERIMENTAL

modified FLOT Docetaxel 40mg/m2 ivgtt day 1 over 1 hour Oxaliplatin 65mg/m2 ivgtt day 1 over 2hours Dose escalation will be performed. Leucovorin 200mg/m2 ivgtt day 1 over 2 hours 5-FU 2200mg/m2 civ over 24 hours

Drug: docetaxel, oxaliplatin, 5-FU, leucovorin

Interventions

docetaxel, oxaliplatin, 5-FU, leucovorin DRUG

This is a single-arm study with all patients receiving mFLOT chemotherapy.

modified FLOT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female patients aged from 18 to 75 years.
• Histologically confirmed gastric adenocarcinoma.
• Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
• At least one measurable lesion should be confirmed by imaging examination.
• ECOG performance status 0 or 1
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥1.5x109/L White blood count ≥3.5x109/L Platelets ≥80x109/L Hemoglobin (Hb) ≥90g/L (can be post-transfusion)
• Adequate renal function: Creatinine Clearance of \>50ml/min
• Adequate liver function:
• Serum bilirubin \<22 umol/L ALT/AST ≤2.5x ULN, for patient with liver metastasis ALT/AST ≤5x ULN 10. Adequate coagulation profile International Normalised Ratio (INR) \< 1.5 Activated Prothrombin Time (APTT) \< 1.5xULN 11. Without brain metastasis and peripheral nerve diseases 12. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

You may not qualify if:

• With second primary malignant diseases
• Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of leucovorin, oxaliplatin, 5-FU or docetaxel
• With uncontrollable complications
• Inadequate organ function
• Pregnancy or of child bearing potential.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jun Zhang, MD & Ph. D

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Oncology

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: July 31, 2018
• Study Start: July 1, 2018
• Primary Completion: November 9, 2019
• Study Completion: January 1, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)