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Primary Objective:
Secondary Objective:
Gemcitabine and cisplatin are drugs that are used in the treatment of many types of cancer. Each acts to kill cancer cells throughout the body.
Before treatment starts, you will have a complete physical exam, pelvic exam, blood tests (about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI. Women able to have children must have a negative blood pregnancy test.
On Day 1 and Day 8, you will receive gemcitabine chemotherapy through a small tube placed in a vein over 1 hour. This will be followed by cisplatin chemotherapy given by vein over 1 hour. Before chemotherapy is given, you will receive medications to prevent nausea. You will not receive any therapy on Day 15. One course of therapy is 3 weeks long.
Routine blood tests (about 1 teaspoon) will be done weekly during treatment and before each course of therapy (every 3 weeks). A complete checkup, including a history and physical exam, pelvic exam, and routine blood tests (about 2-3 teaspoons) will also be done before each course of therapy and a month after treatment ends. CT or MRI scans will be repeated every 2 to 3 cycles and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have the CT or MRI repeated at least 4 weeks later to confirm the response.
You may continue to receive treatment as long as your disease remains stable or improves. Participants who experience significant side effects may be allowed to drop to a lower dose if their disease is not worse. If the disease gets worse or if intolerable side effects occur, you will be taken off study.
When you are taken off the study, a complete medical history and physical exam will be performed. Routine blood tests (about 2-3 teaspoons) will be performed. Any side effects will be monitored until they go away.
This is an investigational study. Both of the study drugs are FDA approved and commercially available, though their use together in this study is investigational. Up to 35 patients will take part in this study. Patients will be enrolled at M.D. Anderson, St. Lukes Episcopal Hospital and The Woman's Hospital of Texas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Cisplatin | Experimental | Gemcitabine 900 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. Cisplatin 30 mg/m^2 by vein over 1 hour on Day 1 and Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 900 mg/m^2 by vein over 1 hour on Day 1 and Day 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Responses | Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD. | Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. |
| Overall Objective Response Rate (CR + PR) | Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 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; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment. | Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jubilee Brown, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Lukes Episcopal Hospital | Houston | Texas | 77030 | United States | ||
| UT MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: August 20, 2004 to December 19, 2008. All recruitment done within medical clinic settings at MD Anderson Cancer Center, St. Luke's Episcopal Hospital and The Woman's Hospital of Texas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Cisplatin | Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant of the 21 enrolled was not evaluable for response or toxicity after transitioning to comfort care without completing the first treatment cycle.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Cisplatin | Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. |
| 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 | Participant Responses | Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD. | Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable. | Posted | Number | participants | Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. |
Participants who receive one or more course(s) of chemotherapy are evaluable for adverse effects regardless of subsequent survival. Course is 21 days. Overall study period: 11/4/04 to 1/1/13.
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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 | Gemcitabine + Cisplatin | Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jubilee Brown, MD/Associate Professor, Gynecology Oncology & Reproductive Medicine | University of Texas (UT) MD Anderson Cancer Center | 713-745-8837 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Cisplatin | Drug | 30 mg/m^2 by vein over 1 hour on Day 1 and Day 8. |
|
|
| Houston |
| Texas |
| 77030 |
| United States |
| The Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Zubrod performance status | Eastern Cooperative Oncology Group (ECOG) performance status (PS) performed at baseline. PS described as 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; etc. | Number | participants |
|
| Tumor Grade | Endometrioid cancer grade based on how much cancer forms glands that look similar to glands found in normal, healthy endometrium. In lower-grade cancers, more of the cancerous tissue forms glands while higher-grade cancers have more of the cancer cells arranged in a disorganized way and do not form glands: Grade 1 tumors: 95%/> of cancerous tissue forming glands; Grade 2: 50% - 94% cancerous tissue form glands; and Grade 3 tumors have less than half of cancerous tissue forming glands. The higher grade, the more aggressive the cancer. | Number | participants |
|
| International Federation of Gynecology & Obstetrics (FIGO) Disease Stage | Number participants with FIGO Stage III or IV or recurrent (any stage) endometrioid endometrial carcinoma. FIGO cancer staging system: IA-Tumor confined to uterus, no or < ½ myometrial invasion; IB-Tumor confined to uterus, > ½ myometrial invasion; I-Cervical stromal invasion, but not beyond uterus; IIIA-Tumor invades serosa or adnexa; IIIB-Vaginal and/or parametrial involvement; IIIC1-Pelvic node involvement; IIIC2- Para-aortic involvement; IVA-Tumor invasion bladder and/or bowel mucosa; IVB-Distant metastases including abdominal metastases and/or inguinal lymph nodes. | Number | participants |
|
| Prior radiotherapy | Number of participants with prior radiotherapy treatments. Prior radiotherapy was allowed, but 2 weeks must have elapsed from its completion, and 6 weeks must have elapsed if radiotherapy involved the whole pelvis or >50% of the spine. | Number | participants |
|
| Prior chemotherapy regimens | Number of participants with none (0), 1, or 2 prior chemotherapy regimens; Participants may have received an unlimited number of prior chemotherapy agents, including platinum-based therapy, but therapy must have been discontinued 3 weeks before study enrollment. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Gemcitabine + Cisplatin | Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8. |
|
|
| Primary | Overall Objective Response Rate (CR + PR) | Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 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; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment. | Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable. | Posted | Number | percentage of participants | Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course. |
|
|
|
| 18 |
| 20 |
| 20 |
| 20 |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal Insufficiency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Related to thrombocytopenia. |
|
| Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatologic effect | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated Serum glutamic oxaloacetic transaminase (SGOT) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Hearing effect | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (abdominal/pelvic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (back) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (extremity) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (headache) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (joint) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain (neck) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal insufficiency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |