NCT00014456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

5.6 years

First QC Date

April 10, 2001

Last Update Submit

August 27, 2013

Conditions

Bladder CancerBreast CancerCarcinoma of Unknown PrimaryEsophageal CancerGastric CancerHead and Neck CancerLung CancerMelanoma (Skin)Ovarian CancerPancreatic CancerProstate CancerSarcoma

Keywords

stage IV breast cancerrecurrent breast cancerstage IV gastric cancerrecurrent gastric cancermetastatic osteosarcomarecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancerchondrosarcomarecurrent adult soft tissue sarcomastage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerextensive stage small cell lung cancerrecurrent small cell lung cancerrecurrent osteosarcomarecurrent bladder cancerstage IV bladder cancerstage IV prostate cancerrecurrent prostate cancerstage IV melanomarecurrent melanomastage IV non-small cell lung cancerstage IV salivary gland cancerrecurrent salivary gland cancerclassic Kaposi sarcomaAIDS-related Kaposi sarcomarecurrent Kaposi sarcomarecurrent metastatic squamous neck cancer with occult primarystage IV ovarian germ cell tumorrecurrent ovarian germ cell tumorstage IV uterine sarcomarecurrent uterine sarcomaborderline ovarian surface epithelial-stromal tumorrecurrent carcinoma of unknown primaryovarian sarcomametastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent verrucous carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavityrecurrent basal cell carcinoma of the lipstage IV basal cell carcinoma of the liprecurrent mucoepidermoid carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV adult soft tissue sarcomastage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

  • Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support

    Four years

  • Define dose limiting adverse events associated with the combination

    Four years

Secondary Outcomes (1)

  • Objective antitumor response

    Four years

Interventions

filgrastimBIOLOGICAL
docetaxelDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (1)

  • 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.

    PMID: 20407240RESULT

MeSH Terms

Conditions

Urinary Bladder NeoplasmsBreast NeoplasmsNeoplasms, Unknown PrimaryEsophageal NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsLung NeoplasmsMelanomaOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsSarcomaOsteosarcomaCarcinoma, Non-Small-Cell LungChondrosarcomaCarcinoma, Ovarian EpithelialSmall Cell Lung CarcinomaSalivary Gland NeoplasmsAIDS-related Kaposi sarcomaSarcoma, KaposiNeuroectodermal Tumors, Primitive, PeripheralSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, Olfactory

Interventions

FilgrastimDocetaxelGemcitabine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeoplasms, Connective TissueCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialCarcinoma, Squamous CellNeuroblastomaOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Konstantin H. Dragnev, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2001

First Posted

January 27, 2003

Study Start

March 1, 2000

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

US(1)