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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00014456   Information provided by National Cancer Institute (NCI)
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 10, 2001
February 6, 2009
March 2000
 
 
Complete list of historical versions of study NCT00014456 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors

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.

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.

Phase I
Interventional
Treatment
  • 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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
 
United States
 
 
NCT00014456
 
DMS-9933, NCI-G01-1933
Norris Cotton Cancer Center
National Cancer Institute (NCI)
Study Chair: Konstantin H. Dragnev, MD Norris Cotton Cancer Center
National Cancer Institute (NCI)
November 2004

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.