NCT00008125

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 gemcitabine combined with docetaxel and carboplatin with or without 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
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 1998

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, 1998

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

5.9 years

First QC Date

January 6, 2001

Last Update Submit

January 14, 2016

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
docetaxelDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor for which no curative therapy exists No symptomatic or uncontrolled brain or leptomeningeal metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 1.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: No unstable cardiac disease requiring treatment No new onset crescendo or rest angina Stable exertion angina allowed Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of contraception for at least 1 week prior to study, during study, and for at least 2 weeks after study No symptomatic peripheral neuropathy greater than grade 1 No significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures No other significant medical or psychiatric condition that would preclude study No active infection No other malignancy within past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer that, due to its stage, is highly unlikely to recur during treatment No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent prophylactic hematopoietic growth factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No more than 1 prior chemotherapy regimen for advanced disease At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Prior cisplatin, carboplatin, docetaxel, paclitaxel, or gemcitabine allowed No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 3 weeks since prior investigational drugs and recovered No other concurrent experimental agents No other concurrent anti-cancer therapy No concurrent prophylactic oral or IV antibiotics without fever present

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

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

FilgrastimCarboplatinDocetaxelGemcitabine

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Chandra P. Belani, MD

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2001

First Posted

May 4, 2004

Study Start

March 1, 1998

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)