Mixed Mullerian Tumors of the Uterus
Conditions
Keywords
oxaliplatin, gemcitabine, MMMT
Brief summary
The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.
Detailed description
OBJECTIVES: Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs). Secondary \* To describe the response rate by Response Evaluation Criteria in Solid Tumors STATISTICAL DESIGN: This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.
Interventions
DRUGGemcitabine
DRUGOxaliplatin
RADIATIONRadiation
Sponsors
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surgically staged and histologically confirmed diagnosis of MMMT * 18 years of age or older * ECOG Performance Score of 0-2 * Adequate bone marrow function * Adequate renal function * Adequate hepatic function * Patients must be recovered from both the acute and late effects of any prior surgery
Exclusion criteria
* Patients with an active infection * Patients with CNS metastases * History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia * Known hypersensitivity to any of the components of oxaliplatin or gemcitabine * Prior radiation to the pelvis * Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days * Peripheral neuropathy greater or equal to Grade 2 * Stage IV visceral disease (lung and liver metastases at presentation) * Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent * Known HIV or Hepatitis B or C (active, previously treated or both) * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy Completion Rate | 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle | Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Therapy Completion Rate | Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. | Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease |
Countries
United States
Participant flow
Recruitment details
20 participants were enrolled between May 2007 and August 2011.
Participants by arm
| Arm | Count |
|---|---|
| Oxaliplatin/ Gemcitabine Then Radiation Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
on | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Alternative therapy | 1 |
| Overall Study | Progressive Disease | 4 |
Baseline characteristics
| Characteristic | Oxaliplatin/ Gemcitabine Then Radiation |
|---|---|
| Age, Continuous | 63 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 19 | 14 / 15 |
| serious Total, serious adverse events | 2 / 19 | 2 / 15 |
Outcome results
Primary
Chemotherapy Completion Rate
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
Time frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Population: The analysis dataset is comprised of all participants who started chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxaliplatin/ Gemcitabine Then Radiation | Chemotherapy Completion Rate | 100 percentage of participants |
Secondary
Radiation Therapy Completion Rate
Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease
Time frame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.
Population: The analysis dataset is comprised of all participants who started chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxaliplatin/ Gemcitabine Then Radiation | Radiation Therapy Completion Rate | 79 percentage of participants |