Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

Phase I Study of Continuous Infusion Gemcitabine

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00020644

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-03-31

Completion date

Unknown

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

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.

Detailed description

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. 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.

Interventions

DRUGgemcitabine hydrochloride

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of an advanced metastatic malignancy for which no curative therapy exists PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior short-infusion gemcitabine allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026