|
|
|
|
|
|
Sponsored by: |
Lutheran General Hospital |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020644 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.
Condition | Intervention | Phase |
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Continuous Infusion Gemcitabine |
Study Start Date: | March 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Illinois | |||||
Lutheran General Cancer Care Center | |||||
Park Ridge, Illinois, United States, 60068 |
Lutheran General Hospital |
Study Chair: | Brian L. Samuels, MD | Lutheran General Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000068691, LGH-3000, NCI-V01-1660 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020644 |
Health Authority: | United States: Federal Government |
|
|
|
|