NCT01525771

Brief Summary

A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

July 18, 2011

Last Update Submit

June 26, 2015

Conditions

Stage IV Gastric Cancer With Metastasis

Keywords

Advanced Gastric cancerXeloda (Capecitabine)CisplatinTaxotere (Docetaxel)

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    Phase I Study \- Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival

    1 year

Secondary Outcomes (4)

  • Safety profile

    1 year

  • Overall survival

    1 year

  • Progression free survival

    1 year

  • efficacy

    1 year

Study Arms (1)

No intervention

NO INTERVENTION

Single-center, open-label, prospective, single-arm, phase I-II study

Other: Docetaxel

Interventions

DocetaxelOTHER

The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients. * Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100) * Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days * Cisplatin 60mg/m2 IV (D1) every 21 days

Also known as: XP with Intraperitoneal Docetaxel, Capecitabine, Cisplatin
No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
  • Peritoneal seeding proven by histology or cytology
  • Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
  • Age 18 to 70 years old
  • Eastern Cooperative Oncology Group performance status \<\_ 2
  • Estimated life expectancy of more than 3 months
  • Adequate bone marrow function (WBCs\>3,000/µL and absolute neutrophil count (ANC) \>1,500/µL and platelets\>100,000/µL),
  • Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance \_\> 60ml/min
  • Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease)
  • Written informed consent

You may not qualify if:

  • Contraindication to any drug contained in the chemotherapy regimen
  • Other tumor type than adenocarcinoma
  • Presence or history of CNS metastasis
  • Gastric outlet or bowel obstruction
  • Evidence of serious gastrointestinal bleeding
  • Peripheral neuropathy \> grade 2
  • History of significant neurologic or psychiatric disorders
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

DocetaxelCapecitabineCisplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Min-Hee Ryu, MD

    Asan Medical Center/Univ of Ulsan

    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
Associate Professor

Study Record Dates

First Submitted

July 18, 2011

First Posted

February 3, 2012

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

KR(1)