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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01525771
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Min-Hee Ryu, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE July 18, 2011
First Posted Date  ICMJE February 3, 2012
Last Update Posted Date June 29, 2015
Study Start Date  ICMJE February 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
Maximum tolerated dose [ Time Frame: 1 year ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
R0 resection rate [ Time Frame: 1 year ]
to assess the R0 resection rate with the study medication.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
  • Safety profile [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
  • Progression free survival [ Time Frame: 1 year ]
  • efficacy [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • Safety profile [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
  • Progression free survival [ Time Frame: 1 year ]
  • Pathologic Complete Response rate [ Time Frame: 1 year ]
  • Angiogenetic biomarkers [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
Official Title  ICMJE A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Gastric Cancer With Metastasis
Intervention  ICMJE 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
Study Arms  ICMJE No Intervention: No intervention
Single-center, open-label, prospective, single-arm, phase I-II study
Intervention: Other: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
37
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01525771
Other Study ID Numbers  ICMJE AMC-XPID-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Min-Hee Ryu, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min-Hee Ryu, MD Asan Medical Center/Univ of Ulsan
PRS Account Asan Medical Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP