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

Sponsor
Samsung Medical Center
Study ID
NCT00539877
Phase
PHASE1
Status
Completed

Conditions

  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2004
Status verified
Jun 2010
Primary completion
Dec 31, 2006
Completion
Aug 31, 2007

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

The objectives of this study are to assess the feasibility, to determine the maximum tolerated dose, and to assess the toxicities of intraperitoneally administered CPT-11 in gastric cancer patients with peritoneal seeding. [ Time Frame: 3 years ]

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