A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
|First Submitted Date ICMJE||November 3, 1999|
|First Posted Date ICMJE||December 10, 2002|
|Last Update Posted Date||March 4, 2008|
|Start Date ICMJE||November 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001495 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors|
|Official Title ICMJE||A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors|
|Brief Summary||This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.|
|Detailed Description||Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: irinotecan (CPT-11)|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||October 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Recurrent or metastatic cancer, including lymphoma.
No active CNS disease.
Refractory to all effective therapy OR No effective therapy exists.
Measurable disease not required.
Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy.
Chemotherapy: Greater than 4 weeks and recovered from chemotherapy.
Previous therapy with irinotecan is permitted.
Endocrine Therapy: Not specified.
Radiotherapy: Greater than 4 weeks since radiotherapy.
Surgery: Recovered from prior surgery.
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic: AGC greater than 1,500.
Platelets greater than 100,000.
Hepatic: Bilirubin no greater than 1.5 mg/dL.
AST no greater than 2 times normal.
Renal: Creatinine no greater than 1.5 mg/dL.
No active infection requiring antibiotics.
No concurrent medical illness that would interfere with chemotherapy.
No pregnant or nursing women.
Adequate contraception required of fertile patients.
Imaging/exams for tumor measurement within 28 days prior to registration.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001495|
|Other Study ID Numbers ICMJE||960013
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP