Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014456
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 28, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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:


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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 : March 2000
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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

Secondary Outcome Measures :
  1. Objective antitumor response [ Time Frame: Four years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • Karnofsky 60-100%
  • ECOG 0-2

Life expectancy:

  • Not specified


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


  • 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


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


  • No congestive heart failure
  • No unstable angina


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


Biologic therapy:

  • Not specified


  • 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


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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014456

United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Study Chair: Konstantin H. Dragnev, MD Norris Cotton Cancer Center

Publications of Results:
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00014456     History of Changes
Other Study ID Numbers: D9933
P30CA023108 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:
stage IV breast cancer
recurrent breast cancer
stage IV gastric cancer
recurrent gastric cancer
metastatic osteosarcoma
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
recurrent adult soft tissue sarcoma
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent osteosarcoma
recurrent bladder cancer
stage IV bladder cancer
stage IV prostate cancer
recurrent prostate cancer
stage IV melanoma
recurrent melanoma
stage IV non-small cell lung cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
classic Kaposi sarcoma

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue