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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Primary Purpose

Bladder Cancer, Breast Cancer, Carcinoma of Unknown Primary

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
docetaxel
gemcitabine hydrochloride
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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, chondrosarcoma, 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, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, recurrent metastatic squamous neck cancer with occult primary, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage IV uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, recurrent carcinoma of unknown primary, ovarian sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent basal cell carcinoma of the lip, stage IV basal cell carcinoma of the lip, recurrent mucoepidermoid carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV adult soft tissue sarcoma, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Outcomes

Primary Outcome Measures

Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support
Define dose limiting adverse events associated with the combination

Secondary Outcome Measures

Objective antitumor response

Full Information

First Posted
April 10, 2001
Last Updated
August 27, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00014456
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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, chondrosarcoma, 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, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, recurrent metastatic squamous neck cancer with occult primary, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage IV uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, recurrent carcinoma of unknown primary, ovarian sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, recurrent basal cell carcinoma of the lip, stage IV basal cell carcinoma of the lip, recurrent mucoepidermoid carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV adult soft tissue sarcoma, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support
Time Frame
Four years
Title
Define dose limiting adverse events associated with the combination
Time Frame
Four years
Secondary Outcome Measure Information:
Title
Objective antitumor response
Time Frame
Four years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin H. Dragnev, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20407240
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. doi: 10.1159/000313526. Epub 2010 Apr 20.
Results Reference
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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

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