Expired Study
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Lebanon, New Hampshire 03756


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

D9933


NCT ID:

NCT00014456


Secondary ID:

P30CA023108


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dartmouth-Hitchcock Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 2000
Completion Date:October 2005
Completion Type:Actual
Primary Completion Date:October 2005
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 27, 2013
First Received Date:April 10, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support
Time Frame:Four years
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Define dose limiting adverse events associated with the combination
Time Frame:Four years
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Objective antitumor response
Time Frame:Four years
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:filgrastim
Intervention Type:Drug
Name:docetaxel
Intervention Type:Drug
Name:gemcitabine hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dartmouth-Hitchcock Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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. Epub 2010 Apr 20.
PMID:20407240

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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