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	Treatment or Intervention	Phase
Cancer	Drug: docetaxel  Drug: filgrastim  Drug: gemcitabine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Renal:

• Creatinine no greater than 2 times ULN OR
• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No congestive heart failure
• No unstable angina

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection
• No known sensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 weeks since prior cytotoxic anti-tumor therapy (4 weeks for nitrosourea or mitomycin) and recovered
• No prior docetaxel or gemcitabine

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 2 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States

Study chairs or principal investigators

Konstantin H. Dragnev, MD,  Study Chair,  Norris Cotton Cancer Center   

Study ID Numbers:  CDR0000068545; DMS-9933; NCI-G01-1933; NCT00014456
Record last reviewed:  January 2005
Last Updated:  January 12, 2005
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014456
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08