Trial Outcomes & Findings for Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer (NCT NCT00238121)
NCT ID: NCT00238121
Last Updated: 2015-11-20
Results Overview
Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2015-11-20
Participant Flow
The study population consisted of patients at least 18 years old with advanced or recurrent carcinoma, or uterine carcinosarcoma. Both cohorts received a starting dose of 400 mg sorafenib orally twice daily on a continuous basis.
A Simon optimal two-stage design was used with objective response rate as the primary efficacy endpoint.
Participant milestones
| Measure |
Carcinoma
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
16
|
|
Overall Study
COMPLETED
|
37
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Carcinoma
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
Baseline characteristics by cohort
| Measure |
Carcinoma
n=40 Participants
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
n=16 Participants
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
64 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
29 participants
n=5 Participants
|
10 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Histology
Adenocarcinoma (unspecified)
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Histology
Serous
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Histology
Clear cell
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Histology
Endometrioid
|
24 participants
n=5 Participants
|
0 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Histology
Carcinosarcoma
|
0 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsResponse was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
Outcome measures
| Measure |
Carcinoma
n=37 Participants
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
n=14 Participants
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Overall Response Rate
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsDefined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.
Outcome measures
| Measure |
Carcinoma
n=38 Participants
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
n=14 Participants
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
11.4 Month
Interval 6.9 to 17.7
|
5 Month
Interval 1.4 to 14.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsDefined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Carcinoma
n=38 Participants
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
n=14 Participants
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival
|
3.2 Month
Interval 1.9 to 4.0
|
1.8 Month
Interval 1.4 to 3.5
|
SECONDARY outcome
Timeframe: Up to 5 yearsDuration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Carcinoma
n=2 Participants
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Carcinosarcoma
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response
|
25 Month
Interval 10.0 to 40.0
|
—
|
Adverse Events
Sorafenib
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib
n=56 participants at risk
|
|---|---|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
1.8%
1/56
|
|
General disorders
Death not associated with CTCAE term : Disease progression NOS
|
3.6%
2/56
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.8%
1/56
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.8%
1/56
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
1.8%
1/56
|
|
Gastrointestinal disorders
Fistula, GI : Colon/cecum/appendix
|
1.8%
1/56
|
|
Reproductive system and breast disorders
Fistula, GU : Vagina
|
1.8%
1/56
|
|
Gastrointestinal disorders
Hemorrhage, GI : Esophagus
|
1.8%
1/56
|
|
Gastrointestinal disorders
Hemorrhage, GI : Lower GI NOS
|
1.8%
1/56
|
|
Renal and urinary disorders
Hemorrhage, GU : Bladder
|
1.8%
1/56
|
|
Renal and urinary disorders
Hemorrhage, GU : Ureter
|
1.8%
1/56
|
|
Vascular disorders
Hypertension
|
1.8%
1/56
|
|
Infections and infestations
Infection with unknown ANC : Bladder (urinary)
|
1.8%
1/56
|
|
Infections and infestations
Infection with unknown ANC : Lung (pneumonia)
|
3.6%
2/56
|
|
Infections and infestations
Infection with unknown ANC : Urinary tract NOS
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
1.8%
1/56
|
|
Gastrointestinal disorders
Pain : Abdomen NOS
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Joint
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
3.6%
2/56
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.8%
1/56
|
Other adverse events
| Measure |
Sorafenib
n=56 participants at risk
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
23.2%
13/56
|
|
Investigations
Alkaline phosphatase
|
28.6%
16/56
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
23.2%
13/56
|
|
Metabolism and nutrition disorders
Anorexia
|
44.6%
25/56
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
32.1%
18/56
|
|
Investigations
Bicarbonate, serum-low
|
8.9%
5/56
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
7.1%
4/56
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
10.7%
6/56
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
25.0%
14/56
|
|
Gastrointestinal disorders
Constipation
|
28.6%
16/56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
9/56
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
24/56
|
|
Nervous system disorders
Dizziness
|
7.1%
4/56
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.9%
10/56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
8/56
|
|
General disorders
Edema: limb
|
17.9%
10/56
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
48.2%
27/56
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.7%
6/56
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
4/56
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
17.9%
10/56
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.4%
3/56
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
28.6%
16/56
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
4/56
|
|
Blood and lymphatic system disorders
Hemoglobin
|
37.5%
21/56
|
|
Gastrointestinal disorders
Hemorrhage, GI : Rectum
|
8.9%
5/56
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory : Nose
|
5.4%
3/56
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory : Respiratory tract NOS
|
5.4%
3/56
|
|
Vascular disorders
Hot flashes/flushes
|
7.1%
4/56
|
|
Vascular disorders
Hypertension
|
32.1%
18/56
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
8.9%
5/56
|
|
Psychiatric disorders
Insomnia
|
12.5%
7/56
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
21.4%
12/56
|
|
Investigations
Lymphopenia
|
25.0%
14/56
|
|
Psychiatric disorders
Mood alteration : Anxiety
|
5.4%
3/56
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) : Oral cavity
|
23.2%
13/56
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) : Extraocular
|
8.9%
5/56
|
|
Gastrointestinal disorders
Nausea
|
35.7%
20/56
|
|
Nervous system disorders
Neuropathy: sensory
|
8.9%
5/56
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
7.1%
4/56
|
|
Respiratory, thoracic and mediastinal disorders
Pain : Larynx
|
7.1%
4/56
|
|
Gastrointestinal disorders
Pain : Abdomen NOS
|
42.9%
24/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Back
|
19.6%
11/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Bone
|
5.4%
3/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Extremity-limb
|
8.9%
5/56
|
|
Nervous system disorders
Pain : Head/headache
|
8.9%
5/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Joint
|
16.1%
9/56
|
|
Musculoskeletal and connective tissue disorders
Pain : Muscle
|
16.1%
9/56
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
26.8%
15/56
|
|
Investigations
Platelets
|
12.5%
7/56
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
26.8%
15/56
|
|
Renal and urinary disorders
Proteinuria
|
5.4%
3/56
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.1%
4/56
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
46.4%
26/56
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
32.1%
18/56
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
35.7%
20/56
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
19.6%
11/56
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia : Sinus tachycardia
|
5.4%
3/56
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
5.4%
3/56
|
|
Respiratory, thoracic and mediastinal disorders
Urinary frequency/urgency
|
5.4%
3/56
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
5.4%
3/56
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
12/56
|
|
Investigations
Weight loss
|
25.0%
14/56
|
Additional Information
Dr. Gini Fleming
University of Chicago Comprehensive Cancer Center
Phone: 773-702-6712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60