Know Cancer

or
forgot password

A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage IV Gastric Cancer With Metastasis

Thank you

Trial Information

A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding


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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome 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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Min-Hee Ryu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center/Univ of Ulsan

Authority:

South Korea: Institutional Review Board

Study ID:

AMC-XPID-1

NCT ID:

NCT01525771

Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

  • Stage IV Gastric Cancer With Metastasis
  • Advanced Gastric cancer
  • Xeloda (Capecitabine)
  • Cisplatin
  • Taxotere (Docetaxel)
  • Stomach Neoplasms
  • Neoplasm Metastasis

Name

Location