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Primary Objectives:
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.
If you are found to be eligible to take part in this study, you will begin treatment. You will have radiation treatment to your pelvis (hip area) every day (Monday - Friday) for a total of 25 treatments. Each treatment should take about 20 minutes to complete.
After the radiation treatment, you will receive a type of radiation called a "vaginal cuff boost." The vaginal cuff boost involves a small device being inserted into the vagina to treat the back of the vagina with a high dose of radiation. The applicator is similar to placing a large tampon in the vagina. This internal treatment takes about 30 minutes for each treatment. This is separate from the external radiation treatments that are given.
While you are receiving radiation treatment, and then afterwards, you will also receive chemotherapy with paclitaxel. During the radiation period, you will receive paclitaxel by vein over 1 hour, on Days 1, 8, 15, 22, and 29. Starting 4-6 weeks after radiation treatment is finished, you will receive paclitaxel at a larger dose, given over 3 hours each time, once every 21 days (3 weeks). You will receive up to 4 "cycles" of chemotherapy, each cycle lasting 21 days.
You will be given certain drugs about 30 minutes before your chemotherapy treatments to help control possible side effects, like allergic reactions. These drugs include dexamethasone, diphenhydramine (Benadryl), and cimetidine.
You will have several tests performed throughout the study. Before each cycle of chemotherapy and one month after the last cycle of chemotherapy is given, quality of life and symptom assessment forms will be completed. These questionnaires should only take about 15 minutes to complete.
While you are on chemotherapy treatment, you will have tests performed before each chemotherapy treatment. This will involve blood (about 1 tablespoon) drawn for routine tests, and a review of your symptoms by the study staff.
Once you are off study treatment, you will be asked to return to the clinic for follow-up visits. These visits will occur every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year after that. At these visits, you will have a physical and pelvic exam performed, along with blood (about 1 tablespoon) drawn for routine tests. Chest x-rays will usually be done once a year and any other diagnostic exams will only be done if your doctor thinks they are needed.
This is an investigational study. There are no standard treatments for this type of endometrial cancer, but radiation and chemotherapy are common treatments. This combination of chemotherapy and radiation is considered experimental. Up to 49 patients will take part in this multicenter study. Up to 44 participants will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel (Taxol) + Pelvic Radiation | Experimental | Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 50 mg/m^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 2 Years and 5 Years | The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year. | Assessment at 2 years and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anuja Jhingran, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. D. Anderson Cancer Center - Orlando | Orlando | Florida | 32806 | United States | ||
| UT MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23385150 | Result | Jhingran A, Ramondetta LM, Bodurka DC, Slomovitz BM, Brown J, Levy LB, Garcia ME, Eifel PJ, Lu KH, Burke TW. A prospective phase II study of chemoradiation followed by adjuvant chemotherapy for FIGO stage I-IIIA (1988) uterine papillary serous carcinoma of the endometrium. Gynecol Oncol. 2013 May;129(2):304-9. doi: 10.1016/j.ygyno.2013.01.025. Epub 2013 Feb 4. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Two participants of 32 were enrolled but not included in group assignment due to ineligibility.
Recruitment Period: April 30, 2001 to November 18, 2009 with actual enrollment occuring October 2001 through July 2009 at University of Texas (UT) MD Anderson Cancer Center and MD Anderson Cancer Center Orlando.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel (Taxol) + Pelvic Radiation | Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel (Taxol) + Pelvic Radiation | Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy. |
| 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 | Overall Survival at 2 Years and 5 Years | The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year. | Two participants were inevaluable. | Posted | Number | percentage of participants | Assessment at 2 years and 5 years |
|
Adverse events elicited at each clinic visit during participation in the study, approximately 15 weeks of treatment with 2 year follow up. Overall study period from November 2001 to December 2009.
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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 (Taxol) + Pelvic Radiation | Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost. Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anuja Jhingran, MD / Professor, Radiation Oncology Department | University of Texas MD Anderson Cancer Center | 713-563-6900 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D018284 | Cystadenocarcinoma, Serous |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D003907 | Dexamethasone |
| D002927 | Cimetidine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Pelvic Radiation | Radiation | Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost. |
|
| Dexamethasone | Drug | 20 mg IV given 30 minutes prior to chemotherapy |
|
| Cimetidine | Drug | 300 mg IV given 30 minutes prior to chemotherapy |
|
| Diphenhydramine | Drug | 50 mg IV given 30 minutes prior to chemotherapy |
|
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 15 |
| 30 |
| 19 |
| 30 |
| FATIGUE | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN, ABDOMEN | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN, CHEST | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN, BONE | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| ANOREXA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIAPHORESIS | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment | Sweating |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| FEVER WITHOUT NEUTROPENIA | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| GLUCOSE, SERUM-HIGH | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| MOTOR SKILL | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUCOSITIS (CLINICAL EXAM) ORAL CAVITY | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| MYALGIA | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (ABDOMEN NOS) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (2.0) | Systematic Assessment | Bone, Extremity-Limb |
|
| RIGORS, CHILLS | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| NEUROPATHY | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| ANOREXIA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| RECTAL BLEEDING | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
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| 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 |
| D003536 | Cystadenocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006146 | Guanidines |
| D000578 | Amidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |