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

Primary Purpose

Mixed Tumor, Mullerian

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Tumor, Mullerian focused on measuring Uterine Neoplasms, Endometrial Cancer, Paclitaxel, Taxol, Carboplatin, Paraplatin, Malignant Mixed Mullerian Tumors, MMMT, Immunohistochemical markers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Loma Linda Cancer Institute
  • MD Anderson Cancer Center
  • Lyndon Baines Johnson Hospital
  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel + Carboplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Overall Response
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.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2007
Last Updated
April 5, 2016
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00502203
Brief Title
Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Tumor, Mullerian
Keywords
Uterine Neoplasms, Endometrial Cancer, Paclitaxel, Taxol, Carboplatin, Paraplatin, Malignant Mixed Mullerian Tumors, MMMT, Immunohistochemical markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel + Carboplatin
Arm Type
Experimental
Arm Description
Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response
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.
Time Frame
24 Months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or recurrent (all stages) MMMT. Prior chemotherapy is permitted with the exception of patients previously treated with platinum and/or taxol chemotherapy for this disease. Women of any racial and ethnic group. Eastern Cooperative Oncology Group (ECOG) performance status </= 2. Expected survival of >/= 12 weeks. Patients must have recovered from the side effects of prior therapy (chemotherapy, surgery, or radiation) before entering the study. 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. Participants must agree to practice approved methods of birth control (if applicable). Patients must sign an institutionally approved informed consent. Exclusion Criteria: Patients with a Zubrod performance status of 3 or greater. Concurrent cancer chemotherapy, radiotherapy or surgery. 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. Presence of known untreated brain metastases. Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with an active systemic infection. Patients with a serious intercurrent medical illness. Patients with a history of neuropsychiatric or seizure disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois M. Ramondetta, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Cancer Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
MD Anderson Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lyndon Baines Johnson Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
The University of Texas M.D.Anderson Cancer Center

Learn more about this trial

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

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