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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
Official Title  A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors
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 Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  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
Intervention  Drug: docetaxel
Drug: filgrastim
Drug: gemcitabine hydrochloride
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  March 2000
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00014456
Organization ID CDR0000068545
Secondary IDs †† DMS-9933, NCI-G01-1933
Study Sponsor  Norris Cotton Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Konstantin H. Dragnev, MD     Norris Cotton Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2004
First Received Date  April 10, 2001
Last Updated Date July 23, 2008

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




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