Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

Advocate Lutheran General Hospital

Status and phase: Unknown; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00020644

NCI-V01-1660

CDR0000068691 (Registry Identifier)

LGH-3000

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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