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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.


Phase 2
N/A
N/A
Not Enrolling
Female
Uterine Neoplasms

Thank you

Trial Information

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.


Patients in this study will have an operation to remove their uterus, tubes, and ovaries
with biopsies of the omentum and lymph nodes before entering this study.

Before treatment starts, patients will have a chest x-ray, computed tomography (CT) scan,
blood tests, and a physical exam. Patients who have a history of hearing loss will have a
hearing test.

Within 8 weeks after surgery, patients will receive 5 weeks of combination radiation therapy
and cisplatin chemotherapy. Radiation and cisplatin will be given on Day 1 or day 2 of each
week followed by 4 days of radiation alone. An additional dose of radiation, directed at
the surface of the vagina, will be given either during the last week (Week 5) of treatment
or after the radiation and cisplatin chemotherapy is finished.

Three to five weeks after radiation therapy and cisplatin chemotherapy is finished, patients
will receive additional chemotherapy. Carboplatin and paclitaxel will be given every 28 days
for 4 cycles. All chemotherapy is given into the vein through a catheter (tube).

Patients will be taken off study if their disease gets worse or intolerable side effects
occur. Patients will be seen one month after the last cycle of chemotherapy, then every 3-4
months from then on for 2 years. At each visit, patients will have blood tests and a
physical exam. Computed tomography (CT) scans will be ordered only if it is suspected that
the disease has come back. All patients will be followed for a maximum of 2 years after
their therapy is completed.

This is an investigational study. Cisplatin, Carboplatin and Paclitaxel are FDA approved
and commercially available. A total of 49 patients will take part in this study. Up to 25
patients may be enrolled at M. D. Anderson Cancer Center in Houston, up to 12 patients will
be enrolled at MD Anderson Cancer Center, Orlando, and up to 12 patients will be enrolled at
the University of Texas Medical Branch in Galveston.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

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

Outcome Time Frame:

7 Years

Safety Issue:

No

Principal Investigator

Lois M. Ramondetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID01-535

NCT ID:

NCT00505492

Start Date:

February 2002

Completion Date:

December 2010

Related Keywords:

  • Uterine Neoplasms
  • Malignant Mixed Mesodermal Tumor
  • MMMT
  • Uterine Neoplasms
  • Radiation Therapy
  • Paclitaxel
  • Carboplatin
  • Cisplatin
  • Taxol
  • Neoplasms
  • Uterine Neoplasms
  • Mixed Tumor, Mesodermal

Name

Location

University of Washington School of MedicineSeattle, Washington  98195
UT MD Anderson Cancer CenterHouston, Texas  77030