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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started

Description

Summary

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Official Title

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma

Details

PRIMARY OBJECTIVES:

I. To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation.

SECONDARY OBJECTIVES:

I. To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.

II. To explore the impact of potential predictors of recurrence or death such as patient age, institution-reported tumor size, cervix involvement (yes or no), and mitotic rate. (exploratory)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo computed tomography (CT) and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.

Arm II: Patients undergo clinical observation.

After completion of study treatment, patients in both arms are followed up every 4 months for 3 years and then every 6 months for 2 years.

Keywords

Stage I Uterine Sarcoma Uterine Corpus Leiomyosarcoma Doxorubicin Liposomal doxorubicin Docetaxel Gemcitabine Lenograstim

Eligibility

You can join if…

Open to females ages 18 years and up

  • Patients with high-risk uterine leiomyosarcoma (LMS), International Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy (BSO) is not required
  • Institutional pathology review calls the uterine leiomyosarcoma "high grade"
  • Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field
  • All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or BSO, the 12 weeks may be counted from the time of the second operation
  • Patients who had a "morcellation" hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma
  • All patients must have no evidence of persistent or metastatic disease as documented by a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CT chest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imaging studies should be performed within 4 weeks of registration on study
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL (ANC>= 1.5 x 10^9/L)
  • Platelets greater than or equal to 100,000/mcL (platelets>= 100 x 10^9/L)
  • Hemoglobin greater than 8.0 g/dL (= 80 g/L or 4.9 mmol/L)
  • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
  • Bilirubin* within normal range
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])*and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])*less than or equal to 2.5 times ULN
  • Alkaline phosphatase* less than or equal to 2.5 x ULN
    • Patients with a history of Gilbert's syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed
  • Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events(CTCAE) grade 1
  • Patients with Gynecologic Oncology Group (GOG) performance status (PS) of 0 or 1 OR Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky PS>= 80%
  • Patients who have met the pre-entry requirements specified
  • Patients must have signed an approved informed consent
  • Patients participating through U.S. sites must sign an approved and authorization permitting release of personal health information
  • Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])

You CAN'T join if...

  • Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years
  • Patients are ineligible if their previous cancer treatment contraindicates this protocol therapy
  • Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel)or other drugs formulated with polysorbate 80
  • Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3 or 4
  • Patients who are breast-feeding
  • Patients with a known history of congestive heart failure or cardiac ejection fraction < 50% (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 of gemcitabine-docetaxel treatment
  • Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50%or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I
  • Patients with a history of whole pelvic radiation
  • Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone-blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician
  • Patients with recurrent uterine LMS
  • Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible
  • Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS

Locations

  • Kaiser Permanente-Deer Valley Medical Center in progress, not accepting new patients
    Antioch, California, 94531, USA
  • Sutter Auburn Faith Hospital withdrawn
    Auburn, California, 95602, USA
  • Sutter Cancer Centers Radiation Oncology Services-Auburn withdrawn
    Auburn, California, 95603, USA
  • Alta Bates Summit Medical Center-Herrick Campus withdrawn
    Berkeley, California, 94704, USA
  • Mills - Peninsula Hospitals withdrawn
    Burlingame, California, 94010, USA
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park withdrawn
    Cameron Park, California, 95682, USA
  • Sutter Davis Hospital withdrawn
    Davis, California, 95616, USA
  • Kaiser Permanente-Fremont in progress, not accepting new patients
    Fremont, California, 94538, USA
  • Memorial Medical Center withdrawn
    Modesto, California, 95355, USA
  • Kaiser Permanente-Modesto in progress, not accepting new patients
    Modesto, California, 95356, USA
  • Palo Alto Medical Foundation-Camino Division withdrawn
    Mountain View, California, 94040, USA
  • Palo Alto Medical Foundation-Gynecologic Oncology withdrawn
    Mountain View, California, 94040, USA
  • Sutter Cancer Research Consortium withdrawn
    Novato, California, 94945, USA
  • Kaiser Permanente-Oakland in progress, not accepting new patients
    Oakland, California, 94611, USA
  • Palo Alto Medical Foundation Health Care withdrawn
    Palo Alto, California, 94301, USA
  • Kaiser Permanente-Redwood City in progress, not accepting new patients
    Redwood City, California, 94063, USA
  • Kaiser Permanente-Richmond in progress, not accepting new patients
    Richmond, California, 94801, USA
  • Kaiser Permanente-Roseville in progress, not accepting new patients
    Roseville, California, 95661, USA
  • Sutter Cancer Centers Radiation Oncology Services-Roseville withdrawn
    Roseville, California, 95661, USA
  • Sutter Roseville Medical Center withdrawn
    Roseville, California, 95661, USA
  • Sutter General Hospital withdrawn
    Sacramento, California, 95816, USA
  • Kaiser Permanente-South Sacramento in progress, not accepting new patients
    Sacramento, California, 95823, USA
  • Kaiser Permanente - Sacramento in progress, not accepting new patients
    Sacramento, California, 95825, USA
  • California Pacific Medical Center-Pacific Campus withdrawn
    San Francisco, California, 94115, USA
  • Kaiser Permanente-San Francisco in progress, not accepting new patients
    San Francisco, California, 94115, USA
  • Kaiser Permanente-Santa Teresa-San Jose in progress, not accepting new patients
    San Jose, California, 95119, USA
  • Kaiser Permanente San Leandro in progress, not accepting new patients
    San Leandro, California, 94577, USA
  • Kaiser Permanente-San Rafael in progress, not accepting new patients
    San Rafael, California, 94903, USA
  • Kaiser Permanente Medical Center - Santa Clara in progress, not accepting new patients
    Santa Clara, California, 95051, USA
  • Palo Alto Medical Foundation-Santa Cruz withdrawn
    Santa Cruz, California, 95065, USA
  • Kaiser Permanente-Santa Rosa in progress, not accepting new patients
    Santa Rosa, California, 95403, USA
  • Sutter Pacific Medical Foundation withdrawn
    Santa Rosa, California, 95403, USA
  • Kaiser Permanente-South San Francisco in progress, not accepting new patients
    South San Francisco, California, 94080, USA
  • Kaiser Permanente-Stockton in progress, not accepting new patients
    Stockton, California, 95210, USA
  • Palo Alto Medical Foundation-Sunnyvale withdrawn
    Sunnyvale, California, 94086, USA
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville withdrawn
    Vacaville, California, 95687, USA
  • Kaiser Permanente Medical Center-Vacaville in progress, not accepting new patients
    Vacaville, California, 95688, USA
  • Kaiser Permanente-Vallejo in progress, not accepting new patients
    Vallejo, California, 94589, USA
  • Sutter Solano Medical Center/Cancer Center withdrawn
    Vallejo, California, 94589, USA
  • Kaiser Permanente-Walnut Creek in progress, not accepting new patients
    Walnut Creek, California, 94596, USA
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center in progress, not accepting new patients
    Burbank, California, 91505, USA
  • Kaiser Permanente in progress, not accepting new patients
    Fresno, California, 93720, USA
  • UC San Diego Moores Cancer Center in progress, not accepting new patients
    La Jolla, California, 92093, USA
  • Loma Linda University Medical Center in progress, not accepting new patients
    Loma Linda, California, 92354, USA
  • Kaiser Permanente Los Angeles Medical Center in progress, not accepting new patients
    Los Angeles, California, 90027, USA
  • Olive View-University of California Los Angeles Medical Center in progress, not accepting new patients
    Sylmar, California, 91342, USA

Details

Status
accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT01533207
Phase
Phase 3
Study Type
Interventional
Last Updated
October 2016