NCT00031629

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim 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. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

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

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

March 8, 2002

Last Update Submit

December 7, 2016

Conditions

Recurrent Uterine Corpus SarcomaUterine Corpus Leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • Frequency and duration of objective response

    Up to 5 years

  • Frequency of severity of observed adverse effects assessed using CTC version 2.0

    The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.

    Up to 5 years

Study Arms (1)

Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)

EXPERIMENTAL

Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF SC on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: DocetaxelBiological: FilgrastimDrug: Gemcitabine HydrochlorideBiological: Pegfilgrastim

Interventions

DocetaxelDRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
FilgrastimBIOLOGICAL

Given SC

Also known as: Filgrastim XM02, Filgrastim-sndz, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim, Zarxio
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011, LY188011
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
PegfilgrastimBIOLOGICAL

Given IV

Also known as: Filgrastim SD-01, filgrastim-SD/01, HSP-130, Neulasta, Neulastim, Pegfilgrastim Biosimilar HSP-130, SD-01, SD-01 sustained duration G-CSF
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed uterine leiomyosarcoma
  • Recurrent or persistent disease that is refractory to curative therapy or established treatments
  • Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Ineligible for a high priority GOG protocol
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.1 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

DocetaxelFilgrastimGranulocyte Colony-Stimulating FactorGemcitabinepegfilgrastim

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Martee Hensley

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

US(1)