Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
NCT ID: NCT00014456
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2000-03-31
2005-10-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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filgrastim
docetaxel
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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Konstantin H. Dragnev, MD
Role: STUDY_CHAIR
Norris Cotton Cancer Center
Locations
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Dragnev KH, Hardin SB, Pipas JM, Davis TH, Rigas JR. A dose escalation trial of biweekly docetaxel and gemcitabine with filgrastim or pegfilgrastim for the treatment of patients with advanced solid tumors. Chemotherapy. 2010;56(2):135-41. doi: 10.1159/000313526. Epub 2010 Apr 20.
Other Identifiers
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DMS-9933
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1933
Identifier Type: -
Identifier Source: secondary_id
D9933
Identifier Type: -
Identifier Source: org_study_id