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| ID | Type | Description | Link |
|---|---|---|---|
| UMN-WCC-38 | Other Identifier | Women's Cancer Center, University of Minnesota | |
| 13062 | Other Identifier | Sanofi-Aventis Pharmaceuticals |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.
After completion of study treatment, patients are followed periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Endometrial Cancer | Experimental | Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Estimated to be Progression-Free and Alive | This estimate was determined by using a statistical method of analysis (Kaplan-Meier). | 1 Year, 2 Years, 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Estimated to be Alive | This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis. | 1 Year, 2 Years, 3 Years |
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Inclusion Criteria:
Histologically confirmed endometrial cancer
Advanced or recurrent disease
Stage IIIB or IIIC disease
Stage IVA or IVB disease
Failed local therapy or considered incurable with local therapy
Measurable or evaluable disease
Performance status Gynecology Oncology Group (GOG) 0-1
Life expectancy at least 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL
Meets 1 of the following criteria:
Bilirubin normal
No acute hepatitis
Creatinine ≤ 1.5 mg/dL
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa A. Geller, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Park Nicollet Cancer Center |
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42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Endometrial Cancer | Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| docetaxel | Drug | 75 mg/m^2 on Day 1 of each course |
|
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| radiation therapy | Radiation | Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy) |
|
|
| Saint Louis Park |
| Minnesota |
| 55426 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Endometrial Cancer | Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Histology | Type or classification of cancer | Number | Participants |
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| 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 | Percent of Patients Estimated to be Progression-Free and Alive | This estimate was determined by using a statistical method of analysis (Kaplan-Meier). | Two patients with recurrent disease at study entry were excluded from this analysis. | Posted | Aug 2010 | Number | Percentage of Patients | 1 Year, 2 Years, 3 Years |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Estimated to be Alive | This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis. | All 41 patients were included in this analysis. | Posted | Aug 2010 | Number | Percentage of Patients | 1 Year, 2 Years, 3 Years |
|
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Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported.
Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).
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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 | Patients With Endometrial Cancer | Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. | 8 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder Infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metastatic disease to lung | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Resulted in death |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stricture/stenosis of ureter | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Endocrine | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Musculoskeletal soft tissue | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Ocular, visual | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pulmonary, upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal, genitourinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Sexual reproductive function | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Geller, M.D. | Masonic Cancer Center, University of Minnesota | 612-626-3111 | gelle005@umn.edu |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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| Hispanic |
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| Other |
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| Unknown |
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| Mucinous |
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| Adenosquamous |
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| Endometroid + Serous |
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| Title | Measurements |
|---|---|
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