Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery (NCT NCT00389974)
NCT ID: NCT00389974
Last Updated: 2015-02-16
Results Overview
It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
Treatment (Sunitinib Malate)
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Sunitinib Malate)
n=19 Participants
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO
|
|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All patients evaluable for response
It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.
Outcome measures
| Measure |
Treatment (Sunitinib Malate)
n=19 Participants
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO
|
|---|---|
|
Objective Response Rate (PR or CR)
|
0 percentage of evalubale patients
Interval 0.0 to 17.6
|
Adverse Events
Treatment (Sunitinib Malate)
Serious events: 14 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Sunitinib Malate)
n=19 participants at risk
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO
|
|---|---|
|
General disorders
Hospitalization for Pain-Pelvis
|
5.3%
1/19
|
|
Gastrointestinal disorders
Fistula
|
5.3%
1/19
|
|
Renal and urinary disorders
Urinary obstruction
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal failure
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal Obstruction
|
5.3%
1/19
|
|
Gastrointestinal disorders
Hospitalization for Bowel Obstruction
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.1%
4/19
|
|
Investigations
Function Liver Tests
|
5.3%
1/19
|
|
Renal and urinary disorders
Hospitalization for Rectovaginal Fistula
|
10.5%
2/19
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Hemorrhage: vagina
|
5.3%
1/19
|
|
General disorders
Chest Pain
|
5.3%
1/19
|
|
General disorders
Pelvic Pain
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Periorbital Edema
|
5.3%
1/19
|
Other adverse events
| Measure |
Treatment (Sunitinib Malate)
n=19 participants at risk
Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.
sunitinib malate: Given PO
|
|---|---|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
10.5%
2/19
|
|
Cardiac disorders
Supraventricular arrhythmia Sinus tachycardia
|
5.3%
1/19
|
|
Cardiac disorders
Hypertension
|
52.6%
10/19
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19
|
|
Cardiac disorders
Pericardial effusion
|
10.5%
2/19
|
|
General disorders
Fatigue
|
89.5%
17/19
|
|
General disorders
Insomnia
|
42.1%
8/19
|
|
General disorders
Patient odor
|
5.3%
1/19
|
|
General disorders
Rigors/chills
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Bruising
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.1%
4/19
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
26.3%
5/19
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Induration
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.1%
8/19
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other (yellowing of the skin)
|
52.6%
10/19
|
|
Endocrine disorders
Hot flashes
|
21.1%
4/19
|
|
Gastrointestinal disorders
Anorexia
|
31.6%
6/19
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19
|
|
Gastrointestinal disorders
Constipation
|
57.9%
11/19
|
|
Gastrointestinal disorders
Diarrhea
|
78.9%
15/19
|
|
Gastrointestinal disorders
Distension
|
21.1%
4/19
|
|
Gastrointestinal disorders
Dry mouth
|
21.1%
4/19
|
|
Gastrointestinal disorders
Enteritis
|
5.3%
1/19
|
|
Gastrointestinal disorders
Fistula, GI Rectum
|
5.3%
1/19
|
|
Gastrointestinal disorders
Fistula, GI Small bowel NOS
|
5.3%
1/19
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19
|
|
Gastrointestinal disorders
Heartburn
|
63.2%
12/19
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.5%
2/19
|
|
Gastrointestinal disorders
Ileus
|
5.3%
1/19
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
52.6%
10/19
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
5.3%
1/19
|
|
Gastrointestinal disorders
Nausea
|
73.7%
14/19
|
|
Gastrointestinal disorders
Taste alteration
|
52.6%
10/19
|
|
Gastrointestinal disorders
Vomiting
|
52.6%
10/19
|
|
Gastrointestinal disorders
GI - Other
|
31.6%
6/19
|
|
Blood and lymphatic system disorders
Hemorrhage pulmonary Nose
|
21.1%
4/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Anus
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Lower GI NOS
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Oral cavity
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Rectum
|
15.8%
3/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GU Bladder
|
10.5%
2/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GU Urinary NOS
|
10.5%
2/19
|
|
Blood and lymphatic system disorders
Hemorrhage, GU Vagina
|
36.8%
7/19
|
|
Infections and infestations
Infection with normal ANC Abdomen NOS
|
5.3%
1/19
|
|
Infections and infestations
Infection with normal ANC Bladder
|
5.3%
1/19
|
|
Infections and infestations
Infection with normal ANC Dental-tooth
|
5.3%
1/19
|
|
Infections and infestations
Infection with normal ANC Skin
|
5.3%
1/19
|
|
Infections and infestations
Iinfection with normal ANC Urinary tract NOS
|
5.3%
1/19
|
|
Infections and infestations
Infection with unknown ANC Bladder
|
5.3%
1/19
|
|
Infections and infestations
Infection with unknown ANC Vagina
|
5.3%
1/19
|
|
Infections and infestations
Opportunistic infection
|
5.3%
1/19
|
|
Infections and infestations
Infection - Other
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
21.1%
4/19
|
|
Blood and lymphatic system disorders
Edema: limb
|
36.8%
7/19
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
5.3%
1/19
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19
|
|
Nervous system disorders
Mood alteration Agitation
|
5.3%
1/19
|
|
Nervous system disorders
Mood alteration Anxiety
|
15.8%
3/19
|
|
Nervous system disorders
Mood alteration Depression
|
5.3%
1/19
|
|
Nervous system disorders
Neuropathy-sensory
|
15.8%
3/19
|
|
Eye disorders
Watery eye
|
5.3%
1/19
|
|
Eye disorders
Ocular - Other
|
5.3%
1/19
|
|
General disorders
Pain Abdomen NOS
|
52.6%
10/19
|
|
General disorders
Pain Back
|
52.6%
10/19
|
|
General disorders
Pain Bladder
|
5.3%
1/19
|
|
General disorders
Pain Bone
|
10.5%
2/19
|
|
General disorders
Pain Chest/thorax NOS
|
21.1%
4/19
|
|
General disorders
Pain Extremity-limb
|
26.3%
5/19
|
|
General disorders
Pain Head/headache
|
42.1%
8/19
|
|
General disorders
Pain Joint
|
10.5%
2/19
|
|
General disorders
Pain Lip
|
5.3%
1/19
|
|
General disorders
Pain Muscle
|
10.5%
2/19
|
|
General disorders
Pain Neck
|
5.3%
1/19
|
|
General disorders
Pain Oral cavity
|
10.5%
2/19
|
|
General disorders
Pain Pelvis
|
36.8%
7/19
|
|
General disorders
Pain Rectum
|
5.3%
1/19
|
|
General disorders
Pain Throat/pharynx/larynx
|
15.8%
3/19
|
|
General disorders
Pain Tumour pain
|
5.3%
1/19
|
|
General disorders
Pain Urethra
|
10.5%
2/19
|
|
General disorders
Pain Vagina
|
10.5%
2/19
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.4%
9/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.4%
9/19
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.5%
2/19
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
10.5%
2/19
|
|
Renal and urinary disorders
Bladder spasms
|
5.3%
1/19
|
|
Renal and urinary disorders
Fistula, GU Bladder
|
5.3%
1/19
|
|
Renal and urinary disorders
Fistula, GU Vagina
|
5.3%
1/19
|
|
Renal and urinary disorders
Leak, GU Urethra
|
5.3%
1/19
|
|
Renal and urinary disorders
Obstruction, GU Urethra
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal failure
|
10.5%
2/19
|
|
Renal and urinary disorders
Urinary frequency
|
15.8%
3/19
|
|
Reproductive system and breast disorders
Vaginal discharge
|
26.3%
5/19
|
Additional Information
Dr. Helen Mackay
Princess Margaret Hospital, Toronto, Canada
Phone: (416) 946-2253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60