Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Neoplasms

Mixed Tumor, Mullerian

Mixed Tumor, Mesodermal

Adenoma, Pleomorphic

Carcinosarcoma

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

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

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

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

Lois M. Ramondetta, MD

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.

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.

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

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.

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

M.D. Anderson Cancer Center

Symptoms and General Pathology

Recurrence

Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.

AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses

175 mg/m\^2 By Vein Over 3 Hours Every 21 Days for 6 Courses

The goal of this clinical research study is to find out if the combination of paclitaxel and carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of the uterus.

Before treatment starts, patients will have a complete check-up, blood tests, a chest x-ray, and a CT scan. Other scans or tests will be done as needed. Women able to have children must have a negative urine pregnancy test. A blood sample will be taken for routine testing once a week during treatment and a month after treatment ends.

Patients will also be asked to complete two questionnaires before they start treatment, before Courses 3 and 5, and at the end of treatment. These questionnaires will help researchers understand how this drug affects patients' daily lives and also identify the side effects caused by this treatment. Each questionnaire will take about 10 minutes to complete.

Patients in this study will be given paclitaxel and carboplatin through a catheter (tube) placed in a vein. Paclitaxel is given first (over 3 hours) followed by carboplatin (over 1 hour). All treatment is given in the outpatient department at M.D. Anderson Cancer Center.

Patients may receive up to 6 courses of treatment. If the disease gets worse or intolerable side effects occur, patients will be taken off study.

-Before each course of treatment, patients will have a checkup. At each checkup, patients will have a physical exam and blood tests. Another CT scan will be done after the third course of treatment. A complete physical exam and a CT scan will also be done at the end of treatment.

This is an investigational study. Both of the study drugs are FDA approved. Their use together in this study is experimental. A total of 50 patients will take part in this multicenter study. About 35 will be enrolled at M. D. Anderson.

Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus

A Phase II Multicenter Trial of Paclitaxel and Carboplatin in Women With Advanced (IIIb, IIIc, IVa and IVb) or Recurrent (All Stages) Malignant Mixed Mullerian Tumors (MMMT) of the Uterus

Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.

Paclitaxel + Carboplatin

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Lois M. Ramondetta, MD / Professor

Thirteen participants had measurable disease therefore evaluable for a complete or partial response.

Number of Participants With Overall Response

Overall Study

Gemcitabine

Oxaliplatin

Antimetabolites

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

Radiation

Susana Campos, MD

The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.

OBJECTIVES:

Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).

Secondary

\* To describe the response rate by Response Evaluation Criteria in Solid Tumors

STATISTICAL DESIGN:

This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.

Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.

Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease

Sanofi

Brigham and Women's Hospital

Massachusetts General Hospital

Dana-Farber Cancer Institute

Medical Oncologist

Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.

Oxaliplatin/ Gemcitabine

On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

on

Oxaliplatin/ Gemcitabine Then Radiation

The baseline population is comprised of all enrolled patients.

Susana M. Campos, MD, MPH

The analysis dataset is comprised of all participants who started chemotherapy.

Chemotherapy Completion Rate

Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Malignant Mixed Mesodermal Tumor (MMMT) - Early Stage With Postoperative XRT/Chemotherapy	NCT00505492	Uterine Neoplas...	Carboplatin Cisplatin Paclitaxel	-	M.D. Anderson Cancer Center
Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus	NCT00502203	Mixed Tumor, Mu...	Carboplatin Paclitaxel	-	M.D. Anderson Cancer Center
Malignant Mixed Mesodermal Tumor (MMMT) - Early Stage With Postoperative XRT/Chemotherapy	NCT00505492	Uterine Neoplas...	Carboplatin Cisplatin Paclitaxel	-	M.D. Anderson Cancer Center
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus	NCT00476086	Mixed Mullerian...	Gemcitabine Oxaliplatin Radiation	18 Years -	Dana-Farber Cancer Institute
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus	NCT00476086	Mixed Mullerian...	Gemcitabine Oxaliplatin Radiation	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for mmmt

Every month we try and update this database with for mmmt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mmmt

Every month we try and update this database with for mmmt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mmmt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.