NCT00014456

Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and filgrastim (G-CSF) in patients with advanced solid tumors. * Determine the dose-limiting toxicity associated with this regimen in these patients. * Assess the objective anti-tumor response in patients treated with this regimen. * Determine fatigue and blood cytokines in patients treated with this regimen. OUTLINE: This is a dose-escalation study of docetaxel. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 2 and continuing until blood counts recover. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Fatigue is assessed at baseline and then at weeks 2, 5, 7, and 9 during therapy. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 15-22 months.

Conditions

• Bladder Cancer
• Breast Cancer
• Carcinoma of Unknown Primary
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Cancer
• Lung Cancer
• Melanoma (Skin)
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2000-03-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2003-01-27
• Last updated: 2013-08-28

Locations

1 site across 1 country: United States