- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539877
Phase I Study of Interperitoneal Chenotherapy in Patients With Gastric Adenocarainoma With Peritoneal Seeding
Study Overview
Detailed Description
Objectives : 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.
Methods : This is open-labeled, non-randomized phase I study in the patients eligible for the following criteria. Patients more than 18 years old with gastric adenocarcinoma, histologically proven, will be enrolled at the time of surgery, and the signed informed consent will be obtained prior to surgery. Preoperative studies should have resectable advanced disease. The operative finding and biopsy of suspected peritoneum must show peritoneal involvement of adenocarcinoma. The subjects should not have any previous chemotherapy, immunotherapy or radiotherapy and any major biological abnormalities. Prior to the initiation of study, patient will receive palliative gastrectomy(total or subtotal) and has a CAPD catheter. Postoperative day 1, IP chemotherapy will be given by CAPD catheter. For dose level 1, CPT-11(provided by CJ Pharmaceutical Company) 50mg/m2 in 1L of normal saline, prewarmed to 37°C will be given intraperitoneally. Plasma samples will be collected prior IP chemotherapy, and samples of plasma, peritoneal fluid and urine will be obtained at 0.5, 1.5, 2, 3.5, 8, 12, and 25.5, 49, 56 hours following chemotherapy. Three patients will be accrued to each dose level. If none of these three patients experienced a dose-limiting toxicity (DLT), the dose will be increased in a subsequent group of three patients to 100 mg/m2.If one of the first three patients experienced DLT, three more patients will be accrued to that dose level. If none of these additional three patients experienced DLT, then the dose will be escalated. If one of the additional three patients experienced DLT, then either an additional cohort of patients could be added or escalation terminated. If two or more of the second group of three patients experienced DLT, then accrual is stopped. If two of the first three patients experienced DLT, then an additional three patients could be accrued at that dose level, but dose escalation could take place only if none of the additional cohort experienced DLT. The last planned dose escalation is to 300 mg/m2. Cohorts of at least 3 patients will be entered at each dose level and monitored for at least 4 weeks after treatment before dose escalation. Intrapatient dose escalation is not permitted.
Dose level Dose of IP CPT-11(mg/m2)
- 50
- 100
- 150
- 200
- 300
In this study, DLT is defined as follows: any grade 4 non-hematologic toxicity or as noted below; ≥ grade 3 diarrhea or stomatitis lasting ≥ 7 days despite optimal supportive care; hematologic dose-limiting toxicity is defined grade 4 neutropenia complicated by fever ≥ 38°C; grade 4 hemorrhage or thrombocytopenia; failure to recover neutrophils (≥ 1500/ mm3) or platelets (≥ 100 000/ mm3) by day 28. The maximal tolerated dose is defined as that dose level that produced dose-limiting toxicity in ≥ 50% of patients. The recommended dose is one level below that. During the study, the evaluation of toxicities will be done daily of postoperative 6 days then weekly using National Cancer Institute-Common Toxicity Criteria (NCI-CTC). Physical examination, complete blood count, and blood chemistry, and serum electrolytes will be measured. Pharmacokinetic study : Plasma, peritoneal fluid and urine samples will be assayed for irinotecan and its metabolites: SN-38, 7-ethyl-10-[4-N-(5-aminopentanoic acid)-1-piperidino] carbonyl camptothecin (APC), and SN-38 glucuronide(SN-38G).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Patients will be eligible for the following criteria are met;
- Histologic diagnosis of gastric adenocarcinoma
- Preoperative studies of resectable disease; endoscopic finding of advanced gastric cancer, radiologic finding of T3 or T4 disease with or without suspicious peritoneal seeding
- Males or females at least 18 years of age
- Performance status 0-1 on the ECOG criteria
- The operative finding and biopsy of suspected peritoneum must show peritoneal involvement of adenocarcinoma
- No previous chemotherapy, immunotherapy or radiotherapy
- No biological major abnormalities.
- Adequate hematologic (WBC count ≥ 4,000/mm3, platelet count ≥ 150,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function.
- Informed consent from patient or patient's relative
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards
Exclusion Criteria:
- Myocardial infarction within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
- Serious concomitant infection
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women
- Women of child bearing potential not using a contraceptive method
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Young Suk Park, M.D.,Ph.D., Samsung medical center, Seoul, Korea
Publications and helpful links
General Publications
- Guichard S, Chatelut E, Lochon I, Bugat R, Mahjoubi M, Canal P. Comparison of the pharmacokinetics and efficacy of irinotecan after administration by the intravenous versus intraperitoneal route in mice. Cancer Chemother Pharmacol. 1998;42(2):165-70. doi: 10.1007/s002800050801.
- Maruyama M, Nagahama T, Yuasa Y. Intraperitoneal versus intravenous CPT-11 for peritoneal seeding and liver metastasis. Anticancer Res. 1999 Sep-Oct;19(5B):4187-91.
- Rosen HR, Jatzko G, Repse S, Potrc S, Neudorfer H, Sandbichler P, Zacherl J, Rabl H, Holzberger P, Lisborg P, Czeijka M. Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicenter trial of the Austrian Working Group for Surgical Oncology. J Clin Oncol. 1998 Aug;16(8):2733-8. doi: 10.1200/JCO.1998.16.8.2733.
- Rothenberg ML, Liu PY, Braly PS, Wilczynski SP, Hannigan EV, Wadler S, Stuart G, Jiang C, Markman M, Alberts DS. Combined intraperitoneal and intravenous chemotherapy for women with optimally debulked ovarian cancer: results from an intergroup phase II trial. J Clin Oncol. 2003 Apr 1;21(7):1313-9. doi: 10.1200/JCO.2003.07.031.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 2004-05-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stomach Neoplasms
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
Chinese University of Hong KongUnknown
-
Chinese University of Hong KongUnknown
-
National Cancer Center, KoreaUnknownSubmucosal Tumor of StomachKorea, Republic of
-
Xijing Hospital of Digestive DiseasesCompletedStomach Cancer | Esophageal Cancer | Esophageal Dysplasia | Stomach DysplasiaChina
-
Chinese University of Hong KongRecruiting
-
Universitätsklinikum Hamburg-EppendorfOvesco Endoscopy AGSuspendedSubmucosal Tumor of StomachGermany
-
Soonchunhyang University HospitalCompletedMalignant Neoplasm of Stomach | Benign Neoplasm of StomachKorea, Republic of
-
Fujian Cancer HospitalCompletedMalignant Neoplasm of Stomach Stage IVChina
-
Federation Francophone de Cancerologie DigestiveEli Lilly and CompanyActive, not recruitingStomach Cancer | Gastric Cancer | Gastroesophageal Junction Adenocarcinoma | Stomach NeoplasmFrance
Clinical Trials on irinotecan
-
Shanghai Zhangjiang Biotechnology Limited CompanyShanghai Biomabs Pharmaceutical Co., Ltd.CompletedMetastatic Colorectal Cancer
-
ShengFa SuUnknownSmall-cell Lung CancerChina
-
Nelson YeeIpsenActive, not recruitingLocally Advanced Pancreatic Carcinoma(LAPC)United States
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedGlioma | Astrocytoma | OligodendrogliomaUnited States
-
Centre Oscar LambretSFCECompleted
-
Boston Scientific CorporationBiocompatibles UK LtdCompletedMetastatic Colorectal CancerUnited Kingdom, Austria, France
-
Baohui HanNot yet recruitingExtensive-stage Small-cell Lung CancerChina
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
Japan Clinical Cancer Research OrganizationTaiho Pharmaceutical Co., Ltd.Completed
-
Dong-A University HospitalPusan National University Yangsan HospitalCompletedGastric CancerKorea, Republic of