|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00001495 |
|
Date of registration:
|
03/11/1999 |
|
Primary sponsor: |
|
|
Public title:
|
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
|
|
Scientific title:
|
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors |
|
Date of first enrolment:
|
November 1995 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00001495 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety Study, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Neoplasms
|
|
Intervention(s)
|
|
Drug: irinotecan (CPT-11)
|
|
Secondary ID(s)
|
|
96-C-0013
|
|
960013
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|