Brief Summary
This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.
Brief Title
Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.
SECONDARY OBJECTIVES:
I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.
OUTLINE:
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma.
SECONDARY OBJECTIVES:
I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen.
OUTLINE:
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Stage IA Uterine Sarcoma
Stage IB Uterine Sarcoma
Stage IC Uterine Sarcoma
Stage IIA Uterine Sarcoma
Stage IIB Uterine Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Eligibility Criteria
Inclusion Criteria:
* Histologically documented uterine leiomyosarcoma with no visible residual disease
* Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
* Patients must be entered no more than 12 weeks post operatively
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Written voluntary informed consent
Exclusion Criteria:
* Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal
* Total serum bilirubin \> 1.5 mg/dl
* History of chronic or active hepatitis
* Serum creatinine \> 2.0 mg/dl
* Platelets \< 100,000/mm3
* Absolute neutrophil count (ANC) \< 1500/mm3
* Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
* Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
* Patients with any prior chemotherapy or radiotherapy for pelvic malignancy
* Patients who have had prior therapy with gemcitabine or docetaxel
* Patients with known hypersensitivity to gemcitabine or docetaxel
* Patients with known hypersensitivity to pegfilgrastim and filgrastim
* Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
* Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
* Histologically documented uterine leiomyosarcoma with no visible residual disease
* Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
* Patients must be entered no more than 12 weeks post operatively
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Written voluntary informed consent
Exclusion Criteria:
* Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal
* Total serum bilirubin \> 1.5 mg/dl
* History of chronic or active hepatitis
* Serum creatinine \> 2.0 mg/dl
* Platelets \< 100,000/mm3
* Absolute neutrophil count (ANC) \< 1500/mm3
* Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
* Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
* Patients with any prior chemotherapy or radiotherapy for pelvic malignancy
* Patients who have had prior therapy with gemcitabine or docetaxel
* Patients with known hypersensitivity to gemcitabine or docetaxel
* Patients with known hypersensitivity to pegfilgrastim and filgrastim
* Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
* Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
Inclusion Criteria
Inclusion Criteria:
* Histologically documented uterine leiomyosarcoma with no visible residual disease
* Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
* Patients must be entered no more than 12 weeks post operatively
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Written voluntary informed consent
* Histologically documented uterine leiomyosarcoma with no visible residual disease
* Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling
* Patients must be entered no more than 12 weeks post operatively
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
* Written voluntary informed consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01958580
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
13-03-096
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma
Primary Outcomes
Outcome Description
Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
Outcome Measure
Recurrence-free Survival
Outcome Time Frame
Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses
Secondary Ids
Secondary Id
NCI-2013-01364
Secondary Id
13-014
Secondary Id
13-03-096
Secondary Id
P30CA013330
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Akiva Novetsky
Investigator Email
ANOVETSK@montefiore.org
Investigator Phone
718-405-8200