Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.

II. Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE:

Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (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.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Given IV

Filgrastim

Intervention Type BIOLOGICAL

Given SC

Gemcitabine Hydrochloride

Intervention Type DRUG

Given IV

Pegfilgrastim

Intervention Type BIOLOGICAL

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

Given IV

Intervention Type DRUG

Filgrastim

Given SC

Intervention Type BIOLOGICAL

Gemcitabine Hydrochloride

Given IV

Intervention Type DRUG

Pegfilgrastim

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Docecad RP56976 Taxotere Taxotere Injection Concentrate Filgrastim XM02 Filgrastim-sndz G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tbo-filgrastim Tevagrastim Zarxio dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011 LY188011 Filgrastim SD-01 filgrastim-SD/01 HSP-130 Neulasta Neulastim Pegfilgrastim Biosimilar HSP-130 SD-01 SD-01 sustained duration G-CSF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* No active infection requiring antibiotics
* No motor or sensory neuropathy greater than grade 1
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease
* At least 3 weeks since prior biologic or immunologic therapy for this disease
* See Disease Characteristics
* See Biologic therapy
* At least 3 weeks since prior chemotherapy and recovered
* No prior docetaxel or gemcitabine
* No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens
* No prior chemotherapy for another malignancy that would preclude study
* At least 1 week since prior hormonal therapy for this disease
* Concurrent hormone replacement therapy allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* See Disease Characteristics
* Recovered from prior recent surgery
* At least 3 weeks since other prior therapy for this disease
* No concurrent amifostine or other protective agents

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martee Hensley

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway United Kingdom United States