A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- 60-day Obstruction Clearance Rate
Study Overview
Brief Summary
This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.
Detailed Description
The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-75 years of age;
- •ECOG PS ≤3;
- •pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
- •peritoneal carcinomatosis established by imaging data or pathological evidence;
- •MBO below the Treitz ligament based on clinical grounds or radiological findings;
- •considered as inoperable MBO by two independent surgical consultants;
- •Hb≥60g/L, WBC ≥4×10E9/L, ANC≥2×10E9/L，PLT≥100×10E9/L;
- •Cr≤ Upper Normal Limit(UNL);
- •Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;
- •Written informed consent form paticipants.
Exclusion Criteria
- •treated by a combination regimen containing all the study drugs;
- •allergy to any of the study drugs;
- •HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
- •strangulated intestinal obstruction;
- •active gastrointestinal bleeding;
- •uncontrolled active infection;
- •unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
- •severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);
- •mental disorders that affect clinical treatment or central nervous system diseases;
- •concomitant cerebral parenchymal or meningeal metastasis;
- •HIV infection or untreated active hepatitis;
- •bowel surgery or stenting required due to obstruction;
- •pregnant or lactating women;
- •other conditions that are not suitable for participation in the study.
Arms & Interventions
A (First-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Fluorouracil (Drug)
C (Third- or Later-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Fluorouracil (Drug)
C (Third- or Later-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Docetaxel (Drug)
A (First-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Docetaxel (Drug)
A (First-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Oxaliplatin (Drug)
B (Second-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Oxaliplatin (Drug)
B (Second-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Docetaxel (Drug)
B (Second-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Fluorouracil (Drug)
C (Third- or Later-Line Therapy)
Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
Intervention: Oxaliplatin (Drug)
Outcomes
Primary Outcomes
60-day Obstruction Clearance Rate
Time Frame: 60 days
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
Secondary Outcomes
- Obstruction Clearance Duration(2 years)
- Safety in terms of Adverse Events(2 years)
- Overall Survival(2 years)
- 30-day Obstruction Clearance Rate(30 days)
- Time to Obstruction Clearance(60 days)
- Quality of Life assessed by EORTC QLQ-OG25(3 months)
Investigators
Jian Xiao
Doctor of Medicine
Guangdong Provincial People's Hospital