Malignant Mixed Mesodermal Tumor (MMMT) - Early Stage With Postoperative XRT/Chemotherapy

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary Objectives:

1. To test whether the addition of chemotherapy to radiotherapy improves the progression-free survival for patients with stage I, II and IIIa malignant mixed mesodermal tumor (MMMT) of the uterus.

2. To determine the acute and late toxicity profiles associated with this treatment regimen.

3. To describe the effect of this treatment regimen on the patient's quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Patients with histologically confirmed malignant mixed mesodermal (MMMT) confined to the pelvis (Stage IB, IC, IIA, IIB, IIIA).

• Patients who have undergone a total abdominal hysterectomy, vaginal hysterectomy or laparoscopic assisted vaginal hysterectomy and a bilateral salpino-oophorectomy (with minimal surgical staging, including omental biopsy and lymph node sampling) within 8 weeks of study entry.

• No known metastatic extrauterine metastases, no known gross residual disease or distant metastases.

• Women of any racial or ethnic group are eligible.

• Zubrod performance status of
• Adequate bone marrow, renal and hepatic function: Hgb > 10 gm/dl, ANC >1.5/mm3, Platelets > 100,000/mcl, Creatinine < 1.5 mg/%, Bilirubin < 2.5 mg/dl, SGPT < 2* ULN, BUN < 1.5* ULN.

• No prior chemotherapy or radiation therapy for this diagnosis.

• Estimated life expectancy of 12 weeks or greater.

• Must sign an institutionally approved informed consent.

Exclusion Criteria:

• Previously treated malignant mixed mesodermal (MMMT) with either chemotherapy or radiotherapy (XRT)/

• Patients with gross residual disease, suspected extrapelvic or extrauterine disease or distant metastatic disease (Stage IIIB, IIIC or IV).

• History of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years.

• Patients with a Zubrod performance status of 3 or greater.

• Patients with an active systemic infection.

• Patients with a serious intercurrent medical illness.

• Patients with a recent (within 6 months) history of cardiac dysrhythmia, congestive heart failure, unstable angina or myocardial infarction.