Clinical trial NCT00448643: Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
Official title: A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometrial Cancer
Keywords: endometrial adenocarcinoma
endometrial clear cell carcinoma
endometrial papillary carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Toxicity as assessed by GOG Common Toxicity Criteria
timeFrame: Study duration
measure: Recommended phase II dose of whole-abdominal radiotherapy
timeFrame: Study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Aaron H. Wolfson, MD
role: STUDY_CHAIR
References: