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

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505492
First received: July 19, 2007
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.

Condition Intervention Phase
Uterine Neoplasms
Drug: Carboplatin
Drug: Cisplatin
Drug: Paclitaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
    Survival defined as observed length of life from study entry until death or, for living patients, date of last contact.


Enrollment: 4
Study Start Date: February 2002
Study Completion Date: December 2010
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation + Chemotherapy
Radiation with weekly Cisplatin 40 mg/m^2 intravenously (IV) Followed by Carboplatin (AUC 5 IV)/Paclitaxel (135 mg/m^2 IV) Chemotherapy every 28 days
Drug: Carboplatin
AUC 5 by vein once every 28 Days
Other Name: paraplatin
Drug: Cisplatin
40 mg/m^2 by vein (IV) Weekly Over 4 Hours
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Paclitaxel
135 mg/m^2 by vein (IV) Once Every 28 Days
Other Name: Taxol

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 </= 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505492

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98104
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505492     History of Changes
Other Study ID Numbers: ID01-535
Study First Received: July 19, 2007
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Malignant Mixed Mesodermal Tumor
MMMT
Uterine Neoplasms
Radiation Therapy
Paclitaxel
Carboplatin
Cisplatin
Taxol

Additional relevant MeSH terms:
Neoplasms
Uterine Neoplasms
Mixed Tumor, Mesodermal
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014