Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Carcinoma, Papillary

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

High-Dose Rate \[HDR\] or Low-Dose Rate \[LDR\], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy

Vaginal Brachytherapy

Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy

Whole Abdominal Radiation Therapy, Dose Escalated \[2-Levels\]; 6 -8 hours after administration of Cisplatin chemotherapy

Whole Abdominal Radiation [WAR] Therapy

Aaron H. Wolfson, MD

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.

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.

Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium

University of Miami

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery	NCT00448643	Endometrial Can...	Vaginal Brachyt... Cisplatin Whole Abdominal...	18 Years - 80 Years	University of Miami
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery	NCT00448643	Endometrial Can...	Vaginal Brachyt... Cisplatin Whole Abdominal...	18 Years - 80 Years	University of Miami

Spots Global Cancer Trial Database for whole abdominal radiation [war] therapy