Intraperitoneal Docetaxel With Cisplatin and TS-ONE for Gastric Cancer With Peritoneal Carcinomatosis

NCT02024841 | Completed Phase 1 DMC

• 1 other identifier: HKUGCDTC01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study on the maximum tolerated dose (MTD) and the recommended dose (RD) of intraperitoneal docetaxel combined with intravenous cisplatin and oral TS-ONE in gastric cancer patients with peritoneal carcinomatosis

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Keywords

Gastric cancer; Peritoneal carcinomatosis; Intraperitoneal docetaxel; Cisplatin; TS-ONE

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose and recommended dose

  2 years

Secondary Outcomes (2)

• Clinical response rate

  12 weeks

• Overall survival

  3 years

Study Arms (1)

Intraperitoneal docetaxel

EXPERIMENTAL

Intraperitoneal docetaxel in 1litre normal saline infused over 1 hour on day 1 every 3 weeks: \- Level I: 40mg/m2; Level II: 50mg/m2; Level III: 60mg/m2 Intravenous cisplatin: 60mg/m2 on day 1 every 3 weeks Oral TS-ONE: 40-60mg twice daily on day 1 -14 every 3 weeks

Drug: Intraperitoneal docetaxel

Interventions

Intraperitoneal docetaxel DRUG

Intraperitoneal docetaxel, intravenous cisplatin and oral TS-ONE every 3 weeks for 3 cycles then stop

Also known as: Intraperitoneal taxotere

Intraperitoneal docetaxel

Eligibility Criteria

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

You may qualify if:

• Age≥18
• Histologic confirmation of gastric adenocarcinoma
• Positive peritoneal cytology or histological proven PC
• Absence of other distant metastases except peritoneum and lymph node(s)
• Adequate bone marrow and organ functions as defined below:
• Leucocyte ≥3.00 x 109/L
• Absolute neutrophil counts ≥ 1.50 x 109/L
• Platelet ≥ 100 x 109/L
• Total bilirubin ≤2 x ULN
• AST/ALT ≤2.5 x ULN
• Creatinine clearance ≥60ml/min
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Subjects of child-bearing potential must agree to contraception from screening to 6 months after completion of treatment
• Provision of written informed consent

You may not qualify if:

• Any prior anti-cancer therapy for gastric cancer
• Previous exposure to taxane, fluoropyrimidine or platinum chemotherapy
• Previous radiotherapy to abdomen or pelvic region
• Known hypersensitivity to study medication
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Any prior or synchronous malignancy, except,
• Malignancy treated with curative intent and with no evidence of disease for ≥5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Subject is pregnant or breast feeding
• Any serious concomitant illness

Sponsors & Collaborators

• The University of Hong Kong: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ka-On Lam, MBBS

  The University of Hong Kong

  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: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)