Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

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

• Registration Number: NCT00014456
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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 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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2001-04-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support	Four years
Define dose limiting adverse events associated with the combination	Four years

Secondary Outcome Measures

Name	Time	Method
Objective antitumor response	Four years

Trial Locations

Locations (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States