Clinical trial · Interventional
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
NCT00476086CI-TRIAL-00034559completedPhase 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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mixed Mullerian Tumors of the Uterus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin/ Gemcitabine Then Radiation
- description
- 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.
- interventionNames
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Radiation: Radiation
Primary outcomes (1)
- measure
- Chemotherapy Completion Rate
- timeFrame
- 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.