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

NCT00505492 | Terminated Phase 2

• 1 other identifier: ID01-535
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objectives:

1. 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. 2.To determine the acute and late toxicity profiles associated with this treatment regimen.
3. 3.To describe the effect of this treatment regimen on the patient's quality of life.

Conditions

Uterine Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

  7 Years

Study Arms (1)

Radiation + Chemotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Paclitaxel

Interventions

Carboplatin DRUG

AUC 5 by vein once every 28 Days

Also known as: paraplatin

Radiation + Chemotherapy

Cisplatin DRUG

40 mg/m\^2 by vein (IV) Weekly Over 4 Hours

Also known as: Platinol-AQ, Platinol, CDDP

Radiation + Chemotherapy

Paclitaxel DRUG

135 mg/m\^2 by vein (IV) Once Every 28 Days

Also known as: Taxol

Radiation + Chemotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98104, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Uterine Neoplasms; Carcinosarcoma

Interventions

Carboplatin; Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Lois M. Ramondetta, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: February 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: December 1, 2010
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

US (2)