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A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors

This study has been completed.
Study NCT00001495.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
Official Title  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  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Neoplasms
Intervention  Drug: irinotecan (CPT-11)
MEDLINE PMIDs 1653362,   8044782
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  40
Start Date  November 1995
Completion Date October 2000
Eligibility Criteria 

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 ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001495
Organization ID 960013
Secondary IDs †† 96-C-0013
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date September 1999
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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