Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
This study has been completed.
Sponsor:
USC/Norris Comprehensive Cancer Center
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00183859
First received: September 9, 2005
Last updated: July 24, 2009
Last verified: July 2009
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Purpose
This is a research study for patients that have an advanced cancer that is confined mostly to the abdominal cavity and have failed treatment with conventional therapy, or for which no standard treatment exists. The purpose of this study is to determine the dose of a chemotherapy drug (called irinotecan) that can be administered safely into the abdominal cavity. We also wish to identify the side effects of irinotecan when it is administered directly into the abdomen. In this study, we will also determine the levels of irinotecan in the blood and in the abdominal cavity.
Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It is approved by the FDA for the treatment of colon cancer. It appears that some other chemotherapy drugs are more effective and may have less side effects when they are administered directly into the abdomen.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma Gastric Cancer |
Drug: irinotecan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan |
Resource links provided by NLM:
Further study details as provided by USC/Norris Comprehensive Cancer Center:
Primary Outcome Measures:
- To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the pharmacokinetics of intra-peritoneal irinotecan. [ Time Frame: One day ] [ Designated as safety issue: No ]
- To determine the toxicity profile of intra-peritoneal irinotecan. [ Time Frame: 30 days after patient receives last dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | September 1999 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Intraperitoneal Irinotecan
|
Drug: irinotecan
Intraperitoneal Irinotecan given every three weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed recurrent, metastatic, or residual cancer with disease confined mostly to the peritoneal cavity. Patients with asymptomatic extra-peritoneal disease are eligible.
- Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis only (documented by cytology or during surgery) are eligible. Patients with ovarian cancer and disease manifested only by an elevated CA-125 are also eligible.
- Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to 2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3 x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.
- SWOG performance status 0-2
- Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation therapy.
- Patients must use an approved method of birth control.
Exclusion Criteria:
- Medical, social, or psychological factors which could prevent patient from receiving treatment.
- Prior therapy with intra-peritoneal irinotecan
- Significant intra-peritoneal adhesions detected clinically or by prior surgical exploration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183859
Locations
| United States, California | |
| U.S.C. / Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Investigators
| Principal Investigator: | Syma Iqbal, M.D. | U.S.C. / Norris Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Syma Iqbal, M.D., U.S.C./Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00183859 History of Changes |
| Other Study ID Numbers: | 0C-99-7 |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
solid tumor phase I phase one |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013