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NCT01012297

PHASE3

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.

Official title: A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2009-11

Completion Date

2015-09

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Recurrent Uterine Corpus Sarcoma Stage IIIA Uterine Sarcoma Stage IIIB Uterine Sarcoma Stage IIIC Uterine Sarcoma Stage IVA Uterine Sarcoma Stage IVB Uterine Sarcoma Uterine Corpus Leiomyosarcoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Docetaxel

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Gemcitabine Hydrochloride

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

OTHER

Placebo

Given IV

Inclusion Criteria: * Patients must have advanced or recurrent uterine leiomyosarcoma with documented disease progression; histologic confirmation of the original primary tumor is required * All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI * Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Patients must have a GOG Performance Status of 0, 1, or 2 * Patients must have recovered from effects of recent surgery, radiotherapy or other therapy * Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI) * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to first day of study treatment; continuation of hormone replacement therapy is permitted * Platelet count greater than or equal to 100,000/mm\^3 * ANC count greater than or equal to 1,500/mm\^3 * Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI CTCAE Version 4.0 Grade 1 * Bilirubin within normal range (CTCAE Version 4 Grade 0) * SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1) * SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1 * Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1 * Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version 4.0. * No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the past 6 months * Urine protein creatinine (UPC) ratio must be \< 1.0 gm; if UPC ratio \>= 1, collection of 24-hour urine measurement of urine protein is recommended * PT such that international normalized ratio (INR) is =\< 1.5 and a PTT =\< 1.5 times the institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must meet pre-entry requirements * Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception Exclusion Criteria: * Patients who have received prior cytotoxic chemotherapy for management of uterine sarcoma; patients who have received prior VEGF-pathway targeted agent such as bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a multi-kinase inhibitor such as sorafenib or sunitinib are not eligible * Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab * Patients with a history of other invasive malignancies, with the exceptions of non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; (necessary use of warfarin or low molecular weight heparin is permitted, provided the INR is maintained in the therapeutic range of approximately 2-3) * Patients with major surgery or significant traumatic injury within 28 days prior to study entry * Patients with a history of abdominal fistula or perforation within the past 12 months * Patients with a current, serious, non-healing wound, ulcer, or bone fracture * Patients with history or evidence upon physical examination of CNS disease, including history of primary brain tumor, or any history of brain metastases, or seizures not controlled with standard medical therapy * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Cardiovascular function; specifically, patient may not have: * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 100 mm Hg in a patient with no history of hypertension; patients with a history of hypertension before enrollment on study are permitted, but such patients must have BP less than or equal to 140/90 mmHg; use of blood pressure medications to achieve and maintain blood pressure control is permitted * Myocardial infarction or unstable angina within 6 months of the first date of bevacizumab/placebo therapy * New York Heart Association (NYHA) Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction \< 50% will be excluded from the study * Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise * History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab/placebo therapy * History of pulmonary embolism or deep vein thrombosis in the past 6 months * Patients with, or with anticipation of, invasive procedures as defined below: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy * Major surgical procedure anticipated during the course of the study. * Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab/placebo therapy * Patients who are pregnant or nursing

Locations (201)

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

John Muir Medical Center-Concord Campus

Concord, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California San Diego

San Diego, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Rocky Mountain Gynecologic Oncology PC

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mercy Hospital

Miami, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Florida Hospital Orlando

Orlando, Florida, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Georgia Regents University Medical Center

Augusta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Memorial University Medical Center

Savannah, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Cadence Cancer Center in Warrenville

Warrenville, Illinois, United States

Elkhart Clinic

Elkhart, Indiana, United States

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Franciscan Saint Francis Health-Indianapolis

Indianapolis, Indiana, United States

Gynecologic Oncology of Indiana

Indianapolis, Indiana, United States

Saint Vincent Oncology Center

Indianapolis, Indiana, United States

Community Howard Regional Health

Kokomo, Indiana, United States

IU Health La Porte Hospital

La Porte, Indiana, United States

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, United States

South Bend Clinic

South Bend, Indiana, United States

Northern Indiana Cancer Research Consortium CCOP

South Bend, Indiana, United States

Michiana Hematology Oncology PC-Westville

Westville, Indiana, United States

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Iowa Methodist Medical Center