Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Phase 2

Completed

• Conditions: Uterine Neoplasm; Leiomyosarcoma
• Interventions: Drug: gemcitabine, docetaxel, doxorubicin

• Registration Number: NCT00282087
• Lead Sponsor: Sarcoma Alliance for Research through Collaboration

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-07-19
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-23
• Last Update Submitted: 2014-11-23
• Results First Posted: 2014-12-01
• Last Update Posted: 2014-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine/docetaxel then doxorubicin	gemcitabine, docetaxel, doxorubicin	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)	2 years
Correlation Between Age and Tumor Response to Treatment (PFS)	2 years
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)	2 years	AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)	2 years	Mitotic rate is measured in mitoses per 10 high-power fields
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)	2 years
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)	2 years
Tolerability/Toxicity of This Regimen	Every 28 days during dosing and then every 3 months thereafter until patient comes off study	Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)	2 years
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)	2 years	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)

Trial Locations

Locations (12)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Pennsylvania Oncology Hematology Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

Massachusetts General; 🇺🇸 Boston, Massachusetts, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Winship Cancer Institute at Emory University; 🇺🇸 Atlanta, Georgia, United States

St. Vincent Gynecologic Oncology; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Nebraska Methodist Hospital; 🇺🇸 Omaha, Nebraska, United States

Washington Cancer Institute/Washington Hospital Center (Medstar); 🇺🇸 Washington, District of Columbia, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States