Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00014456

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride	Phase 1

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

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2000

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

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

Objective antitumor response [Four years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced solid tumor that is not curable by surgery or radiotherapy
Sarcoma
Melanoma
Carcinoma of unknown primary
Pancreatic cancer
Lung cancer
Ovarian cancer
Breast cancer
Bladder cancer
Gastric cancer
Esophageal cancer
Prostate cancer
Head and neck cancer
No hematopoietic or lymphoid tumors
Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

Karnofsky 60-100%
ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin normal
AST and/or ALT no greater than 5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
Alkaline phosphatase no greater than 5 times ULN if AST and ALT no greater than ULN OR
AST and/or ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than 2.5 times ULN