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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502203
First received: July 16, 2007
Last updated: December 5, 2011
Last verified: December 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Lyndon Baines Johnson Hospital
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502203     History of Changes
Other Study ID Numbers: ID01-229
Study First Received: July 16, 2007
Results First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board

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:
Adenoma, Pleomorphic
Mixed Tumor, Mullerian
Carcinosarcoma
Mixed Tumor, Mesodermal
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Sarcoma
Neoplasms, Connective and Soft Tissue
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014