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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Sarcoma

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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

- 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.

- 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: This is a multicenter study. Patients are stratified according to country of
treating site. 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 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

- 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

- No patients with recurrent uterine LMS

- No patients with gross residual or metastatic tumor findings following complete
surgical treatment for uterine LMS

PATIENT CHARACTERISTICS:

- 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 glutamic 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 NOTE: * Patients with a history
of Gilbert syndrome may be eligible provided total bilirubin is less than or equal to
1.5 x ULN and AST, ALT, and alkaline phosphatase meet the criteria above.

- 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 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])

- 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

- No patients with a history of severe hypersensitivity reaction to Taxotere®
(docetaxel) or other drugs formulated with polysorbate 80

- No patients who are breast-feeding

- No 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
starting treatment

- Patients who are known to be HIV (human immunodeficiency virus) positive are not
eligible

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or
doxorubicin hydrochloride at any time in their history

- No patients with a history of whole pelvic radiation

- Patients are ineligible if their previous cancer treatment contraindicates this
protocol therapy

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

ongoing

Safety Issue:

No

Principal Investigator

Martee L. Hensley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: National Cancer Institute

Study ID:

GOG-0277

NCT ID:

NCT01533207

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Sarcoma
  • uterine leiomyosarcoma
  • stage IA uterine sarcoma
  • stage IB uterine sarcoma
  • stage IC uterine sarcoma
  • Leiomyosarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Batte Cancer Center at Northeast Medical CenterConcord, North Carolina  28025
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Vince Lombardi Cancer Clinic - SheboyganSheboygan, Wisconsin  53081
Rocky Mountain OncologyCasper, Wyoming  82609
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Gynecologic OncologyHinsdale, Illinois  60521
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - OshkoshOshkosh, Wisconsin  54904
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
St. Vincent Oncology CenterIndianapolis, Indiana  46260
Mercy Clinic Cancer and Hematology - RollaRolla, Missouri  65401
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700