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COMPLETED Phase 2

Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

NCT00101127 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.

Conditions Studied

Interventions

  • DRUG docetaxel
  • BIOLOGICAL filgrastim
  • BIOLOGICAL pegfilgrastim
  • DRUG gemcitabine hydrochloride

Study Locations (20)

Illinois

  • Rush-Copley Cancer Care Center — Aurora
  • Rush University Medical Center — Chicago
  • University of Chicago Cancer Research Center — Chicago
  • Hinsdale Hematology Oncology Associates — Hinsdale
  • Joliet Oncology-Hematology Associates, Limited - West — Joliet
  • Carle Cancer Center at Carle Foundation Hospital — Urbana
  • CCOP - Carle Cancer Center — Urbana

Georgia

  • MBCCOP-Medical College of Georgia Cancer Center — Augusta
  • Medical Center of Central Georgia — Macon
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center — Savannah

California

  • Kaiser Permanente Medical Center - Los Angeles — Los Angeles
  • Jonsson Comprehensive Cancer Center at UCLA — Los Angeles

Connecticut

  • Helen and Harry Gray Cancer Center at Hartford Hospital — Hartford
  • New Britain General Hospital — New Britain

Delaware

  • CCOP - Christiana Care Health Services — Newark

Indiana

  • Saint Anthony Memorial Health Centers — Michigan City

Iowa

  • Holden Comprehensive Cancer Center at University of Iowa — Iowa City

Louisiana

  • Woman's Hospital — Baton Rouge

Trial Details

FieldValue
Start Date 2003-12
Phase Phase 2

Sponsor

Gynecologic Oncology Group

61 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00101127

The ClinicalTrials.gov registry entry for NCT00101127 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Gynecologic Oncology Group, which has 61 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 4 interventions — of which docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00101127 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Illinois, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00101127 about?

NCT00101127 is a clinical study titled "Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma". RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells foun...

What is the current status of trial NCT00101127?

This trial is currently completed. It is a Phase 2 study. The study started on 2003-12.

What conditions does trial NCT00101127 study?

This clinical trial studies the following conditions: Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00101127?

The interventions under investigation include: docetaxel (DRUG), filgrastim (BIOLOGICAL), pegfilgrastim (BIOLOGICAL), gemcitabine hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00101127?

This trial is sponsored by Gynecologic Oncology Group, which has 61 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00101127 being conducted?

This trial has 20 study locations across California, Connecticut, Delaware, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial