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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Min-Hee Ryu, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01525771
First received: July 18, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Stage IV Gastric Cancer With Metastasis
Other: Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Single-center, open-label, prospective, single-arm, phase I-II study
Other: Docetaxel

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
Other Names:
  • XP with Intraperitoneal Docetaxel
  • Capecitabine
  • Cisplatin

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525771

Contacts
Contact: Kyu-pyo Kim, MD +82-2-3010-5913 kkp1122@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Min-Hee Ryu, MD    82-2-3010-5935    miniryu@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Min-Hee Ryu, MD Asan Medical Center/Univ of Ulsan
  More Information

No publications provided

Responsible Party: Min-Hee Ryu, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01525771     History of Changes
Other Study ID Numbers: AMC-XPID-1
Study First Received: July 18, 2011
Last Updated: April 22, 2013
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Advanced Gastric cancer
Xeloda (Capecitabine)
Cisplatin
Taxotere (Docetaxel)

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Docetaxel
Capecitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014