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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel + Carboplatin | Experimental | Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lois M. Ramondetta, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Cancer Institute | Loma Linda | California | 92354 | United States | ||
| MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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Recruitment period: August 29, 2001 to May 08, 2009. All recruitment was done at medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Thirteen participants had measurable disease therefore evaluable for a complete or partial response. | Posted | Number | participants | 24 Months |
|
7 years and 11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lois M. Ramondetta, MD / Professor | UT MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D018200 | Mixed Tumor, Mullerian |
| D014594 | Uterine Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005833 | Genital Neoplasms, Female |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Paclitaxel | Drug | 175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses |
|
|
| Orlando |
| Florida |
| 32806 |
| United States |
| Lyndon Baines Johnson Hospital | Houston | Texas | 77030 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 9 |
| 23 |
| 23 |
| 23 |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy (sensory) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy (hearing) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenic Fever | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |