Trial Outcomes & Findings for Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer (NCT NCT00388154)
NCT ID: NCT00388154
Last Updated: 2014-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.
Results posted on
2014-11-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin
n=21 Participants
Gemcitabine 900 mg/m\^2 and Cisplatin 30 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8.
|
|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
|
Zubrod performance status
0
|
15 participants
n=93 Participants
|
|
Zubrod performance status
1
|
6 participants
n=93 Participants
|
|
Tumor Grade
Grade 1
|
1 participants
n=93 Participants
|
|
Tumor Grade
Grade 2
|
12 participants
n=93 Participants
|
|
Tumor Grade
Grade 3
|
8 participants
n=93 Participants
|
|
International Federation of Gynecology & Obstetrics (FIGO) Disease Stage
III
|
0 participants
n=93 Participants
|
|
International Federation of Gynecology & Obstetrics (FIGO) Disease Stage
IV
|
5 participants
n=93 Participants
|
|
International Federation of Gynecology & Obstetrics (FIGO) Disease Stage
Recurrent
|
16 participants
n=93 Participants
|
|
Prior radiotherapy
No
|
7 participants
n=93 Participants
|
|
Prior radiotherapy
Yes
|
14 participants
n=93 Participants
|
|
Prior chemotherapy regimens
0
|
12 participants
n=93 Participants
|
|
Prior chemotherapy regimens
1
|
6 participants
n=93 Participants
|
|
Prior chemotherapy regimens
2
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.Population: 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.
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.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=20 Participants
Gemcitabine 900 mg/m\^2 and Cisplatin 30 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8.
|
|---|---|
|
Participant Responses
CR
|
2 participants
|
|
Participant Responses
PR
|
8 participants
|
|
Participant Responses
PD
|
4 participants
|
|
Participant Responses
SD
|
6 participants
|
PRIMARY outcome
Timeframe: Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.Population: 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.
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.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=20 Participants
Gemcitabine 900 mg/m\^2 and Cisplatin 30 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8.
|
|---|---|
|
Overall Objective Response Rate (CR + PR)
|
50 percentage of participants
|
Adverse Events
Gemcitabine + Cisplatin
Serious events: 18 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Cisplatin
n=20 participants at risk
Gemcitabine 900 mg/m\^2 and Cisplatin 30 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8.
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
4/20 • 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.
|
|
General disorders
Fatigue
|
20.0%
4/20 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.0%
3/20 • 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.
|
|
Renal and urinary disorders
Renal Insufficiency
|
10.0%
2/20 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.0%
1/20 • 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.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • 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.
|
|
Infections and infestations
Neutropenia
|
25.0%
5/20 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
5/20 • 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.
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin
n=20 participants at risk
Gemcitabine 900 mg/m\^2 and Cisplatin 30 mg/m\^2 by vein (IV) over 1 hour on Day 1 and Day 8.
|
|---|---|
|
Immune system disorders
Allergy
|
5.0%
1/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.0%
9/20 • 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.
|
|
Gastrointestinal disorders
Anorexia
|
40.0%
8/20 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • 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.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
10/20 • 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.
|
|
Gastrointestinal disorders
Dehydration
|
10.0%
2/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatologic effect
|
10.0%
2/20 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • 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.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
8/20 • 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.
|
|
Blood and lymphatic system disorders
Edema
|
20.0%
4/20 • 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.
|
|
Metabolism and nutrition disorders
Elevated Serum glutamic oxaloacetic transaminase (SGOT)
|
5.0%
1/20 • 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.
|
|
General disorders
Fatigue
|
85.0%
17/20 • 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.
|
|
Infections and infestations
Fever
|
25.0%
5/20 • 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.
|
|
Ear and labyrinth disorders
Hearing effect
|
10.0%
2/20 • 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.
|
|
Blood and lymphatic system disorders
Hematuria
|
5.0%
1/20 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.0%
9/20 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.0%
3/20 • 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.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
4/20 • 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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.0%
7/20 • 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.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
55.0%
11/20 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
5/20 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • 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.
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • 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.
|
|
Infections and infestations
Infection
|
25.0%
5/20 • 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.
|
|
Psychiatric disorders
Mood alteration
|
45.0%
9/20 • 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.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy
|
30.0%
6/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain (abdominal/pelvic)
|
25.0%
5/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
20.0%
4/20 • 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.
|
|
Renal and urinary disorders
Pain (bladder)
|
5.0%
1/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain (extremity)
|
10.0%
2/20 • 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.
|
|
Nervous system disorders
Pain (headache)
|
40.0%
8/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain (joint)
|
15.0%
3/20 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain (neck)
|
5.0%
1/20 • 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.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 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.
|
|
Gastrointestinal disorders
Proctitis
|
5.0%
1/20 • 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.
|
|
Renal and urinary disorders
Renal insufficiency
|
10.0%
2/20 • 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.
|
|
General disorders
Rigors
|
25.0%
5/20 • 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.
|
|
Vascular disorders
Thrombosis
|
5.0%
1/20 • 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.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
5/20 • 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.
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
10/20 • 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.
|
|
Infections and infestations
Neutropenia
|
40.0%
8/20 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
16/20 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
8/20 • 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.
|
Additional Information
Jubilee Brown, MD/Associate Professor, Gynecology Oncology & Reproductive Medicine
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-8837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place