Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01533207
• Date of registration: 11/02/2012
• Prospective Registration: Yes
• Primary sponsor: Gynecologic Oncology Group
• Public title: Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
• Scientific 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
• Date of first enrolment: June 4, 2012
• Target sample size: 38
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01533207
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, France, Netherlands, Norway, Spain, United Kingdom, United States, Venezuela

Contacts

• Name: Martee L Hensley
• Affiliation: NRG Oncology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with high-risk uterine leiomyosarcoma (LMS), 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 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 bilateral salpingo-oophorectomy (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/liter [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 of 0 or 1 OR Eastern
Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky performance status (PS) >=
80%

- Patients who have met the pre-entry requirements specified

- Patients must have signed an approved informed consent

- Patients participating through United States (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])

Exclusion Criteria:

- 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 also 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 prior 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; documentation of concurrent
medications is required

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Corpus Leiomyosarcoma

Stage I Uterine Sarcoma AJCC v7

Intervention(s)

Drug: Doxorubicin Hydrochloride

Other: Clinical Observation

Drug: Docetaxel

Drug: Gemcitabine Hydrochloride

Biological: Pegfilgrastim

Biological: Filgrastim

Primary Outcome(s)

Number of Participants Who Experienced Death [Time Frame: Follow-up every 4 months for 3 years, then every 6 months for 2 years.]

Secondary Outcome(s)

Number of Participants With Recurrence [Time Frame: Follow-up every 4 months for 3 years, then every 6 months for 2 years.]

Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [Time Frame: Approximately 4 years]

Secondary ID(s)

U10CA180868

U10CA027469

IRCI 001

GOG-0277

CDR0000724874

NCI-2012-00249

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Results

• Results available: Yes
• Date Posted: 06/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01533207