Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/16/2016 |
| Start Date: | May 2002 |
| End Date: | March 2011 |
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also
make tumor cells more sensitive to cisplatin. Giving radiation therapy together with
cisplatin after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal
radiation therapy when given together with cisplatin in treating patients with stage III or
stage IV endometrial cancer that has been removed by surgery.
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also
make tumor cells more sensitive to cisplatin. Giving radiation therapy together with
cisplatin after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal
radiation therapy when given together with cisplatin in treating patients with stage III or
stage IV endometrial cancer that has been removed by surgery.
OBJECTIVES:
- Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when
administered with cisplatin in patients with optimally debulked stage III or IV
carcinoma of the endometrium.
OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel
IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive
cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment
with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last
course of standard chemotherapy or no later than 1 week before the start of cisplatin and
WAR.
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose
(RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of
6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when
administered with cisplatin in patients with optimally debulked stage III or IV
carcinoma of the endometrium.
OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel
IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive
cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment
with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last
course of standard chemotherapy or no later than 1 week before the start of cisplatin and
WAR.
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose
(RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of
6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of endometrial cancer, including any of the following cellular types:
- Papillary serous carcinoma
- Clear cell carcinoma
- Adenocarcinoma
- Stage III or IV disease
- No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or
supraclavicular nodes)
- Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian
tube and ovary, and resection of any palpable lymph nodes in the pelvis and
para-aortic region (or surgical sampling of these nodal regions if no palpable nodes
were present) within the past 6 weeks
- Peritoneal washings must have been collected for cytological evaluation
- Must have ≤ 1 cm residual disease after surgery
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- WBC ≥ 3,000/mm^3
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine < 2.0 mg/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Lactate dehydrogenase < 3 times ULN
- Gamma glutamyl transferase < 3 times ULN
- SGPT and SGOT < 3 times ULN
- Alkaline phosphatase < 3 times ULN
- No other malignant tumor within the past 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the whole abdomen and/or pelvis/vagina
- No systemic chemotherapy within the past 5 years
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