MedTrace Logo

Phase I Study of Interperitoneal Chenotherapy in Patients With Gastric Adenocarainoma With Peritoneal Seeding

NCT00539877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2010-06-23

No results posted yet for this study

Summary

Stomach cancer is the most common cancer, and is still leading cause of death in Korea. Peritoneal seeding is the most common metastases of gastric cancer, and is the most frequent cause of death from this disease. In addition, there is no standard treatment for peritoneal dissemination. Even though systemic intravenous chemotherapy is the standard treatment for metastatic stomach cancer at present, it does not improve the survival of patients with peritoneal dissemination. Because intraperitoneal(IP) administration results in high concentration locally with low systemic toxicity, clinical investigators have confirmed the safety and pharmacokinetic advantage associated with IP delivery of a number of antineoplastic agents with known activity in cancer. In ovarian cancer, a large randomized trial demonstrated a small but statistically and clinically significant survival advantage for women receiving a portion of their therapy intraperitoneally. Drugs such as 5-fluorouracil, cisplatin, mitomycin-C, paclitaxel and docetaxel are used for IP chemotherapy in patients with gastric cancer. Even the small number of phase III trials reported, some studies showed improvement in survival for patients randomized to IP therapy compared to those receiving no postoperative treatment. Irinotecan(7-ethyl-10-\[4-(1-pipperidino)-1-piperidino\] carbonyloxy camptothecin; CPT-11), clinically effective in the treatment of colorectal, lung and gastric cancer, is a carbamate prodrug metabolized to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38). In mouse model, IP administration of CPT-11 was significantly more effective than intravenous administration for control of both peritoneal seeding and liver metastasis. However, phamacokinetics of CPT-11 with peritoneal administration in human beings is not well studied. Although Japanese investigators reported pharmacokinetic data of CPT-11 with few patients, there is no data about maximum tolerated dose of CPT-11 intraperitoneally.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

irinotecan

Postoperative day 1, IP CPT-11 chemotherapy will be given by CAPD catheter. CPT-11 in 1L of normal saline, prewarmed to 37°C will be given intraperitoneally. If there is no DLT and patients agree with the treatment, patients can receive 3 more times of IP chemotherapy with same dose of CPT-11 at 3 weeks interval. After total 4 cycles of IP chemotherapy, peritoneal disease will be reassessed with abdominal-pelvis CT. Pharmacokinetic study is not planned with this treatment.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Young Suk Park, M.D.,Ph.D. · Samsung Medical Center, Seoul, Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-12-31
Completion
2007-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539877 on ClinicalTrials.gov