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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stage IV Gastric Cancer With Metastasis Other: Docetaxel Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety profile [ Time Frame: 1 year ]
  2. Overall survival [ Time Frame: 1 year ]
  3. Progression free survival [ Time Frame: 1 year ]
  4. efficacy [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525771


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Min-Hee Ryu, MD Asan Medical Center/Univ of Ulsan
More Information
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Responsible Party: Min-Hee Ryu, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01525771    
Other Study ID Numbers: AMC-XPID-1
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015
Keywords provided by Min-Hee Ryu, Asan Medical Center:
Advanced Gastric cancer
Xeloda (Capecitabine)
Cisplatin
Taxotere (Docetaxel)
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
 Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites