Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Treatment | Closed | 18 and over | Other | LGH-3000 NCI-V01-1660, NCT00020644 |
Objectives
- Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies.
- Determine the toxicity profile of this drug in these patients.
Entry Criteria
Disease Characteristics:
- Diagnosis of an advanced metastatic malignancy for which no curative therapy exists
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Prior short-infusion gemcitabine allowed
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 2.0 mg/dL
Pulmonary:
- Corrected DLCO at least 60% expected
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment
A total of 27 patients will be accrued for this study.
Outline
This is a dose-escalation study.
Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1. Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
Trial Lead Organizations
Advocate Lutheran General Cancer Care Center
 | | | ||
| Brian Samuels, MD, Protocol chair(Contact information may not be current) | |
| ||
| ||||
| Registry Information | ||
| ||
| Official Title | Phase I Study of Continuous Infusion Gemcitabine | |
| ||
| Trial Start Date | 2000-03-30 | |
| ||
| Registered in ClinicalTrials.gov | NCT00020644 | |
| ||
| Date Submitted to PDQ | 2001-05-01 | |
| ||
| Information Last Verified | 2004-04-27 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
