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Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer (XPID)

Primary Purpose

Stage IV Gastric Cancer With Metastasis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Gastric Cancer With Metastasis focused on measuring Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
  2. Peritoneal seeding proven by histology or cytology
  3. 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)
  4. Age 18 to 70 years old
  5. Eastern Cooperative Oncology Group performance status <_ 2
  6. Estimated life expectancy of more than 3 months
  7. Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),
  8. Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min
  9. 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)
  10. Written informed consent

Exclusion Criteria:

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

No intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety profile
Overall survival
Progression free survival
efficacy

Full Information

First Posted
July 18, 2011
Last Updated
June 26, 2015
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01525771
Brief Title
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
Acronym
XPID
Official Title
A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Single-center, open-label, prospective, single-arm, phase I-II study About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Gastric Cancer With Metastasis
Keywords
Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Single-center, open-label, prospective, single-arm, phase I-II study
Intervention Type
Other
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
XP with Intraperitoneal Docetaxel, Capecitabine, Cisplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety profile
Time Frame
1 year
Title
Overall survival
Time Frame
1 year
Title
Progression free survival
Time Frame
1 year
Title
efficacy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Hee Ryu, MD
Organizational Affiliation
Asan Medical Center/Univ of Ulsan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

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