Clinical trial · Interventional
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
NCT00282087CI-TRIAL-00016168completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyosarcoma | Leiomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Uterine Neoplasm | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine, docetaxel, doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- gemcitabine/docetaxel then doxorubicin
- 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).
- interventionNames
- Drug: gemcitabine, docetaxel, doxorubicin
Primary outcomes (1)
- measure
- Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
- timeFrame
- Every 3 months up to two years
Secondary outcomes (9)
- measure
- Tolerability/Toxicity of This Regimen
- timeFrame
- Every 28 days during dosing and then every 3 months thereafter until patient comes off study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHensley 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