Trial Outcomes & Findings for Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma (NCT NCT00282087)

NCT ID: NCT00282087

Last Updated: 2014-12-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Every 3 months up to two years
• Results posted on: 2014-12-01

Participant Flow

This was multi-center study open at 11 major medical centers across the United States.

Participant milestones

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
Overall Study STARTED	47
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
Overall Study Death	1

Baseline Characteristics

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Baseline characteristics by cohort

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months up to two years

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=46 Participants
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS	78 percentage of participants Interval 67.0 to 91.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=46 Participants
Tolerability/Toxicity of This Regimen	6 number of major toxicity events

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between Age and Tumor Response to Treatment (PFS)	53 years Interval 37.0 to 70.0

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) Postmenopausal	43 participants
Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) Premenopausal	4 participants

SECONDARY outcome

Timeframe: 2 years

AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) AJCC Stage I	0 participants
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) AJCC Stage II	6 participants
Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) AJCC Stage III	41 participants

SECONDARY outcome

Timeframe: 2 years

Mitotic rate is measured in mitoses per 10 high-power fields

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)	18 mitoses per 10 high-power fields Interval 5.0 to 83.0

SECONDARY outcome

Timeframe: 2 years

Population: Only 38 of the 47 patients were evaluable

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=38 Participants
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) Positive Status	24 participants
Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) Negative Status	14 participants

SECONDARY outcome

Timeframe: 2 years

Population: Only 38 of the 47 patients were evaluable

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=38 Participants
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) Positive Status	19 participants
Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) Negative Status	19 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) FIFO Stage I	38 participants
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) FIGO Stage II	7 participants
Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) FIGO Stage III	2 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 Participants
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) ER or PR Positive	33 participants
Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) ER and PR Negative	14 participants

Adverse Events

Women Treated With Adjuvant Regimen for High Risk Uterine LMS

Serious events: 9 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 participants at risk
Gastrointestinal disorders Perforation of bowel	2.1% 1/47 • Number of events 1
Injury, poisoning and procedural complications Hernia	2.1% 1/47 • Number of events 1
Gastrointestinal disorders Colostomy Reversal	2.1% 1/47 • Number of events 1
Cardiac disorders Chest Pain	4.3% 2/47 • Number of events 2
Blood and lymphatic system disorders Neutropenia	4.3% 2/47 • Number of events 2
Investigations Neutrophils	4.3% 2/47 • Number of events 2
Gastrointestinal disorders Diarrhea	2.1% 1/47 • Number of events 1
Respiratory, thoracic and mediastinal disorders Throat Pain	2.1% 1/47 • Number of events 1
Investigations Bilirubin	2.1% 1/47 • Number of events 1
Investigations Platelets	2.1% 1/47 • Number of events 1
General disorders Fever	2.1% 1/47 • Number of events 1
Infections and infestations Infection	2.1% 1/47 • Number of events 1
Blood and lymphatic system disorders Blood clot	2.1% 1/47 • Number of events 1
Blood and lymphatic system disorders Renal insufficiency	2.1% 1/47 • Number of events 1
Skin and subcutaneous tissue disorders Cellulitis	2.1% 1/47 • Number of events 1

Other adverse events

Measure	Women Treated With Adjuvant Regimen for High Risk Uterine LMS n=47 participants at risk
Endocrine disorders myelosuppression	29.8% 14/47
Immune system disorders Hypersensitivity	21.3% 10/47
Nervous system disorders neuropathy	6.4% 3/47
Skin and subcutaneous tissue disorders Edema	4.3% 2/47

Additional Information

Research Project Manager

SARC

Phone: (734) 930-7600

Email: sarc@sarctrials.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place