NCT00282087 · REGISTRY CONDITION SEARCH

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-12-01

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

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outcome · POSTED

Tolerability/Toxicity of This Regimen

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outcome · POSTED

Correlation Between Age and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)

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outcome · POSTED

Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * ≥ 18 years of age * high risk uterine LMS, FIGO stage I or II * pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf * no longer than 12 weeks from surgical resection of cancer * no evidence of residual disease * ECOG 0 or 1 * ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000 * creatinine ≤ 1.5 x institutional upper limits of normal * adequate liver function * neuropathy (sensory and motor) ≤ CTC grade 1 * negative pregnancy test * signed consent Exclusion Criteria: * patients with other invasive malignancies * prior therapy with gemcitabine or docetaxel or doxorubicin * hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * women who are breast feeding * cardiac ejection fraction \<50% * prior pelvic irradiation * treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).
intervention Names
Drug: gemcitabine, docetaxel, doxorubicin
label
gemcitabine/docetaxel then doxorubicin
type
OTHER

interventions

arm Group Labels
gemcitabine/docetaxel then doxorubicin
description
Cycles = 28 days
name
gemcitabine, docetaxel, doxorubicin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 47
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
time Frame
Every 3 months up to two years

secondary Outcomes

description
Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
measure
Tolerability/Toxicity of This Regimen
time Frame
Every 28 days during dosing and then every 3 months thereafter until patient comes off study
measure
Correlation Between Age and Tumor Response to Treatment (PFS)
time Frame
2 years
measure
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)
time Frame
2 years
description
AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
measure
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)
time Frame
2 years
description
Mitotic rate is measured in mitoses per 10 high-power fields
measure
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)
time Frame
2 years
measure
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)
time Frame
2 years
measure
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)
time Frame
2 years
description
Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)
measure
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)
time Frame
2 years
measure
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)
time Frame
2 years

Full study description

brief Summary: The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.
detailed Description: Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Source references

references

citation
Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18.
pmid
23335221
type
DERIVED