mFLOT Chemotherapy as First-line Treatment in GC

Phase 1

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: docetaxel, oxaliplatin, 5-FU, leucovorin

• Registration Number: NCT03606928
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

The RP2D of FLOT regime will be established with a standard 3+3 design, starting with the dose of 40mg/m2 docetaxel (dose level 1) and 65mg/m2 oxaliplatin (dose level 1). The plan of dose escalation will be found in following table. Chemotherapy will be administered two-weekly (maximum 12 cycles) until progression of disease, intolerable toxicity or withdraw of patients.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-28
• Study First Posted: 2018-07-31
• Primary Completion: 2019-11-09
• Study Completion: 2020-01-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Male/female patients aged from 18 to 75 years.

2. Histologically confirmed gastric adenocarcinoma.

3. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.

4. At least one measurable lesion should be confirmed by imaging examination.

5. ECOG performance status 0 or 1

6. 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)

7. Adequate renal function: Creatinine Clearance of >50ml/min

8. 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified FLOT	docetaxel, oxaliplatin, 5-FU, leucovorin	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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose and recommended phase II dose of modified FLOT regime	36 months
Objective response rate	36 months

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events as assessed by CTCAE v4.0	36 months
Overall survival	36 months
Progression free survival	36 months

Trial Locations

Locations (1)

Department of Oncology, Ruijin Hospital; 🇨🇳 Shanghai, China