Clinical Trial: Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Dartmouth-Hitchcock Medical Center

Current Primary Outcome:

  • Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support [ Time Frame: Four years ]
  • Define dose limiting adverse events associated with the combination [ Time Frame: Four years ]


Original Primary Outcome:

Current Secondary Outcome: Objective antitumor response [ Time Frame: Four years ]

Original Secondary Outcome:

Information By: Dartmouth-Hitchcock Medical Center

Dates:
Date Received: April 10, 2001
Date Started: March 2000
Date Completion:
Last Updated: August 27, 2013
Last Verified: August 2013