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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00505492

Purpose

Primary Objectives:

To test whether the addition of chemotherapy to XRT improves the progression-free survival for patients with stage I, II and IIIa malignant mixed mesodermal tumor (MMMT) of the uterus.
To determine the acute and late toxicity profiles associated with this treatment regimen.
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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Adjuvant Postoperative Radiation With Cisplatin Followed by Carboplatin/Paclitaxel Chemotherapy Following TAH/BSO for Patients With Stage I, II and IIIa Malignant Mixed Mesodermal Tumor (MMMT) of the Uterus.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy Uterine Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin

U.S. FDA Resources

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

Primary Outcome Measures:

To study whether the combination of chemotherapy and radiation therapy will help control mixed malignant mesodermal tumors of the uterus. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	49
Study Start Date:	February 2002
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Carboplatin + Cisplatin + Paclitaxel	Drug: Carboplatin AUC 5 IV Once Every 28 Days Drug: Cisplatin 40 mg/m^2 IV Weekly Over 4 Hours Drug: Paclitaxel 135 mg/m^2 IV Once Every 28 Days

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, 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. 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 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 < 2x ULN, BUN < 1.5x 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 MMMT with either chemotherapy or 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

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

Locations

United States, Texas
U.T.M.D. 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

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Lois M. Ramondetta, MD/Associate Professor )
Study ID Numbers:	ID01-535
Study First Received:	July 19, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00505492 History of Changes
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

Study placed in the following topic categories:

Genital Neoplasms, Female
Adjuvants, Immunologic
Uterine Diseases
Malignant Mixed Mullerian Tumor
Urogenital Neoplasms
Carboplatin
Antimitotic Agents

Genital Diseases, Female
Cisplatin
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Pharmacologic Actions

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009