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

NCT00101127 | Completed Phase 2 DMC

• 2 other identifiers: GOG-0087LCDR0000405892
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 60

Brief 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

Sarcoma

Keywords

recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; uterine leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Antitumor activity

• Toxicity

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

docetaxel DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed uterine leiomyosarcoma * Advanced, persistent, or recurrent disease * Documented disease progression * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are considered nontarget lesions * Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * Adult Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No neuropathy (sensory or motor) \> grade 1 * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No active infection requiring antibiotics * No known hypersensitivity to E. coli-derived proteins PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy for the malignancy Endocrine therapy * At least 1 week since prior hormonal therapy for the malignancy * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy Surgery * Recovered from prior surgery Other * Recovered from all other prior therapy * No prior cancer treatment that would preclude study treatment * No concurrent amifostine or other protective agents

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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (60)

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06050, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70815, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, 08053, United States

Location

UMDNJ University Hospital

Newark, New Jersey, 07103, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

New York Oncology Hematology, PC at Albany Regional Cancer Care

Albany, New York, 12208, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

Hope A Women's Cancer Center

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Drexel University College of Medicine - Center City Hahnemann Campus

Philadelphia, Pennsylvania, 19102, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Baptist Centers for Cancer Care

Memphis, Tennessee, 38120, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (1)

• Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008 Jun;109(3):329-34. doi: 10.1016/j.ygyno.2008.03.010.

  PMID: 18534250 RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Filgrastim; pegfilgrastim; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Martee L. Hensley, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

• Gregory P. Sutton, MD

  St. Vincent Gynecologic Oncology at St. Vincent Oncology Center

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: December 1, 2003
• Primary Completion: July 1, 2006
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (60)