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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


Phase 2
N/A
N/A
Not Enrolling
Female
Mixed Tumor, Mullerian

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or
recurrent (all stages) MMMT.

2. Prior chemotherapy is permitted with the exception of patients previously treated
with platinum and/or taxol chemotherapy for this disease.

3. Women of any racial and ethnic group.

4. Eastern Cooperative Oncology Group (ECOG) performance status
5. Expected survival of >/= 12 weeks.

6. Patients must have recovered from the side effects of prior therapy (chemotherapy,
surgery, or radiation) before entering the study.

7. Adequate liver, renal, and bone marrow function, defined as: a total bilirubin value
normal or creatinine /= 1,500/ul; platelet
count >/= 100,000/ul. All qualifying laboratory parameters must be determined within
1 week prior to first treatment.

8. Participants must agree to practice approved methods of birth control (if
applicable).

9. Patients must sign an institutionally approved informed consent.

Exclusion Criteria:

1. Patients with a Zubrod performance status of 3 or greater.

2. Concurrent cancer chemotherapy, radiotherapy or surgery.

3. History of other malignancy (except nonmelanoma skin cancer or carcinoma in situ of
the cervix), unless in complete remission and off all therapy for that disease for a
minimum of 5 years.

4. Presence of known untreated brain metastases.

5. Overt psychosis or mental disability or otherwise incompetent to give informed
consent.

6. Patients with an active systemic infection.

7. Patients with a serious intercurrent medical illness.

8. Patients with a history of neuropsychiatric or seizure disorders.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Overall Response

Outcome Description:

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.

Outcome Time Frame:

24 Months

Safety Issue:

No

Principal Investigator

Lois M. Ramondetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID01-229

NCT ID:

NCT00502203

Start Date:

August 2001

Completion Date:

November 2010

Related Keywords:

  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Endometrial Cancer
  • Paclitaxel
  • Taxol
  • Carboplatin
  • Paraplatin
  • Malignant Mixed Mullerian Tumors
  • MMMT
  • Immunohistochemical markers
  • Adenoma, Pleomorphic
  • Mixed Tumor, Mullerian
  • Carcinosarcoma
  • Mixed Tumor, Mesodermal

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030
MD Anderson Cancer Center Orlando, Florida  32806
Lyndon Baines Johnson Hospital Houston, Texas  77026
Loma Linda Cancer Institute Loma Linda, California  92354