NCT00004066

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 II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Jun 1999

Typical duration for phase_2 ovarian-cancer

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

June 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

4.3 years

First QC Date

December 10, 1999

Last Update Submit

March 6, 2013

Conditions

Ovarian CancerSarcomaSmall Intestine Cancer

Keywords

adult leiomyosarcomarecurrent adult soft tissue sarcomasmall intestine leiomyosarcomastage IV uterine sarcomarecurrent uterine sarcomauterine leiomyosarcomaovarian sarcomarecurrent small intestine cancerstage IV adult soft tissue sarcoma

Interventions

filgrastimBIOLOGICAL
docetaxelDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma * No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas * Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy * No prior chemotherapy OR * Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma * Bidimensionally measurable disease by physical examination or medical imaging techniques * Ascites and pleural effusions are not considered measurable disease * No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Other: * No active or uncontrolled infection * No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix * No history of grade 3 or 4 peripheral neuropathy * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior gemcitabine or docetaxel Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. doi: 10.1200/JCO.2002.11.050.

    PMID: 12065559RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsSarcomaLeiomyosarcoma

Interventions

FilgrastimDocetaxelGemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Muscle Tissue

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

  • Robert Maki, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

June 1, 1999

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)