|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | November 1995 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001495 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| 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 Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety Study |
| Condition ICMJE | Neoplasms |
| Intervention ICMJE | Drug: irinotecan (CPT-11) |
| Study Arms / Comparison Groups | |
| Publications * |
|
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 40 |
| Completion Date | October 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Recurrent or metastatic cancer, including lymphoma. No leukemia. No active CNS disease. Refractory to all effective therapy OR No effective therapy exists. Measurable disease not required. PRIOR/CONCURRENT THERAPY: 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. PATIENT CHARACTERISTICS: 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. OTHER: HIV negative. 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001495 |
| Responsible Party | |
| Study ID Numbers ICMJE | 960013, 96-C-0013 |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | 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 |
|