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Phase I Study of Continuous Infusion Gemcitabine


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Continuous Infusion Gemcitabine


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian L. Samuels, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lutheran General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000068691

NCT ID:

NCT00020644

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Lutheran General Cancer Care CenterPark Ridge, Illinois  60068