Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Completed · Phase 1
Conditions studied: Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
In brief
This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
Key facts
- Study ID
- NCT00005840
- Run by
- Gynecologic Oncology Group
- People needed
- 35
- Starts
- 2000-07-01
- Last updated by the study team
- 2014-12-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed surgical stage III or IV endometrial cancer
- Any stage clear or serous papillary endometrial cancer
- Positive para-aortic lymph nodes allowed
- Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
- Must have had hysterectomy and bilateral salpingo-oophorectomy
- No recurrent disease
- No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
- Performance status - GOG 0-2
- Absolute neutrophil count greater than 2,000/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 3 times ULN
- Creatinine no greater than 1.5 times ULN
- No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
- No prior chemotherapy
- No prior radiotherapy
- See Disease Characteristics
- No more than 8 weeks since prior surgery
- No prior anticancer therapy that would preclude study
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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