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Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer



Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Lutheran General Cancer Care Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BrianSamuels,  Study Chair,  Lutheran General Cancer Care Center

Lutheran General Cancer Care Center *Recruiting*
Park Ridge,  Illinois,  60068
United States
Recruiting Brian  Samuels 847-268-8200


Additional Information:
Study ID Numbers:  CDR0000068691;  LGH-3000,NCI-V01-1660
Study Start Date: 
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020644

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2. Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors

3. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors

4. Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors

5. Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy

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Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
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