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Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00388154
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : November 13, 2014
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Endometrial Cancer
Interventions Drug: Gemcitabine
Drug: Cisplatin
Enrollment 21
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Gemcitabine + Cisplatin
Hide Arm/Group Description Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
Period Title: Overall Study
Started 21
Completed 20
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Gemcitabine + Cisplatin
Hide Arm/Group Description Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
One participant of the 21 enrolled was not evaluable for response or toxicity after transitioning to comfort care without completing the first treatment cycle.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
62
(41 to 75)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  90.5%
>=65 years
2
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
21
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  14.3%
White
17
  81.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
1
   4.8%
Not Hispanic or Latino
20
  95.2%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
Zubrod performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 21 participants
0 15
1 6
[1]
Measure Description: 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.
Tumor Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 21 participants
Grade 1 1
Grade 2 12
Grade 3 8
[1]
Measure Description: 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.
International Federation of Gynecology & Obstetrics (FIGO) Disease Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 21 participants
III 0
IV 5
Recurrent 16
[1]
Measure Description: 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.
Prior radiotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 21 participants
No 7
Yes 14
[1]
Measure Description: 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.
Prior chemotherapy regimens   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 21 participants
0 12
1 6
2 3
[1]
Measure Description: 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.
1.Primary Outcome
Title Participant Responses
Hide Description 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.
Time Frame Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gemcitabine + Cisplatin
Hide Arm/Group Description:
Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
CR 2
PR 8
PD 4
SD 6
2.Primary Outcome
Title Overall Objective Response Rate (CR + PR)
Hide Description 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.
Time Frame Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Gemcitabine + Cisplatin
Hide Arm/Group Description:
Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
50
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine + Cisplatin
Hide Arm/Group Description Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
All-Cause Mortality
Gemcitabine + Cisplatin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Gemcitabine + Cisplatin
Affected / at Risk (%)
Total   18/20 (90.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia † 1  5/20 (25.00%) 
General disorders   
Fatigue † 1  4/20 (20.00%) 
Infections and infestations   
Neutropenia † 1  5/20 (25.00%) 
Metabolism and nutrition disorders   
Hypokalemia † 1  4/20 (20.00%) 
Hyperglycemia † 1  3/20 (15.00%) 
Renal and urinary disorders   
Renal Insufficiency † 1  2/20 (10.00%) 
Hematuria † 1 [1]  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism † 1  1/20 (5.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Related to thrombocytopenia.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine + Cisplatin
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Edema † 1  4/20 (20.00%) 
Hematuria † 1  1/20 (5.00%) 
Anemia † 1  16/20 (80.00%) 
Thrombocytopenia † 1  8/20 (40.00%) 
Cardiac disorders   
Atrial fibrillation † 1  1/20 (5.00%) 
Hypotension † 1  1/20 (5.00%) 
Palpitations † 1  1/20 (5.00%) 
Ear and labyrinth disorders   
Hearing effect † 1  2/20 (10.00%) 
Tinnitus † 1  5/20 (25.00%) 
Gastrointestinal disorders   
Anorexia † 1  8/20 (40.00%) 
Constipation † 1  10/20 (50.00%) 
Dehydration † 1  2/20 (10.00%) 
Diarrhea † 1  6/20 (30.00%) 
Nausea † 1  14/20 (70.00%) 
Proctitis † 1  1/20 (5.00%) 
Vomiting † 1  10/20 (50.00%) 
General disorders   
Fatigue † 1  17/20 (85.00%) 
Rigors † 1  5/20 (25.00%) 
Immune system disorders   
Allergy † 1  1/20 (5.00%) 
Infections and infestations   
Fever † 1  5/20 (25.00%) 
Infection † 1  5/20 (25.00%) 
Neutropenia † 1  8/20 (40.00%) 
Metabolism and nutrition disorders   
Elevated Serum glutamic oxaloacetic transaminase (SGOT) † 1  1/20 (5.00%) 
Hyperglycemia † 1  9/20 (45.00%) 
Hyperkalemia † 1  3/20 (15.00%) 
Hypernatremia † 1  1/20 (5.00%) 
Hypocalcemia † 1  4/20 (20.00%) 
Hypokalemia † 1  7/20 (35.00%) 
Hypomagnesemia † 1  11/20 (55.00%) 
Hyponatremia † 1  5/20 (25.00%) 
Hypophosphatemia † 1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Neuropathy † 1  6/20 (30.00%) 
Pain (abdominal/pelvic) † 1  5/20 (25.00%) 
Pain (back) † 1  4/20 (20.00%) 
Pain (extremity) † 1  2/20 (10.00%) 
Pain (joint) † 1  3/20 (15.00%) 
Pain (neck) † 1  1/20 (5.00%) 
Nervous system disorders   
Dizziness † 1  1/20 (5.00%) 
Pain (headache) † 1  8/20 (40.00%) 
Psychiatric disorders   
Mood alteration † 1  9/20 (45.00%) 
Renal and urinary disorders   
Pain (bladder) † 1  1/20 (5.00%) 
Renal insufficiency † 1  2/20 (10.00%) 
Urinary tract infection † 1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea † 1  8/20 (40.00%) 
Skin and subcutaneous tissue disorders   
Alopecia † 1  9/20 (45.00%) 
Dermatologic effect † 1  2/20 (10.00%) 
Vascular disorders   
Thrombosis † 1  1/20 (5.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jubilee Brown, MD/Associate Professor, Gynecology Oncology & Reproductive Medicine
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-8837
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00388154    
Other Study ID Numbers: 2003-0823
First Submitted: October 12, 2006
First Posted: October 16, 2006
Results First Submitted: November 5, 2014
Results First Posted: November 13, 2014
Last Update Posted: November 13, 2014