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

NCT00505492TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

M.D. Anderson Cancer Center

Enrollment

4

Start Date

2002-02-01

Completion Date

2006-02-01

Study Type

INTERVENTIONAL

Official Title

A Phase II Study of Adjuvant Postoperative Radiation With Cisplatin Followed by Carboplatin/Paclitaxel Chemotherapy Following Total Abdominal Hysterectomy/Bilateral Salpino-Oophorectomy (TAH/BSO) for Patients With Stage I, II and IIIa Malignant Mixed Mesodermal Tumor (MMMT) of the Uterus.

Interventions

CarboplatinCisplatinPaclitaxel

Conditions

Uterine Neoplasms

Eligibility

Sex

FEMALE

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 \</= 2.
* 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.

Outcome Measures

Primary Outcomes

Overall Survival

Survival defined as observed length of life from study entry until death or, for living patients, date of last contact.

Time frame: 7 Years

Locations

UT MD Anderson Cancer Center, Houston, United States

University of Washington School of Medicine, Seattle, United States

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