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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502203
First Posted: July 17, 2007
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention Phase
Mixed Tumor, Mullerian Drug: Carboplatin Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Overall Response [ Time Frame: 24 Months ]
    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.


Enrollment: 23
Study Start Date: August 2001
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel + Carboplatin
Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Drug: Carboplatin
AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses
Other Name: Paraplatin
Drug: Paclitaxel
175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
Other Name: Taxol

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 </= 2.
  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 </= 1.5 mg/dL; serum glutamic pyruvic transaminase (SGPT) </= 2 times upper limit of normal or </= 5 times upper limit of normal when liver metastases are present; serum creatinine </= 1.5 mg/dL; Absolute neutrophil count (ANC) >/= 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502203


Locations
United States, California
Loma Linda Cancer Institute
Loma Linda, California, United States, 92354
United States, Florida
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
United States, Texas
Lyndon Baines Johnson Hospital
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502203     History of Changes
Other Study ID Numbers: ID01-229
First Submitted: July 16, 2007
First Posted: July 17, 2007
Results First Submitted: December 5, 2011
Results First Posted: January 9, 2012
Last Update Posted: May 9, 2016
Last Verified: December 2011

Keywords provided by M.D. Anderson Cancer Center:
Uterine Neoplasms
Endometrial Cancer
Paclitaxel
Taxol
Carboplatin
Paraplatin
Malignant Mixed Mullerian Tumors
MMMT
Immunohistochemical markers

Additional relevant MeSH terms:
Mixed Tumor, Mullerian
Carcinosarcoma
Mixed Tumor, Mesodermal
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action