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Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389974
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Stage IVB Cervical Cancer
Intervention Drug: sunitinib malate
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description

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 Number of Baseline Participants 19
Hide Baseline Analysis Population Description
All treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
44
(28 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
19
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 19 participants
19
1.Primary Outcome
Title Objective Response Rate (PR or CR)
Hide Description 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.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients evaluable for response
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description:

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 Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of evalubale patients
0
(0 to 17.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   14/19 (73.68%) 
Blood and lymphatic system disorders   
Hemorrhage: vagina  1  1/19 (5.26%) 
Periorbital Edema  1  1/19 (5.26%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1  1/19 (5.26%) 
Gastrointestinal disorders   
Fistula  1  1/19 (5.26%) 
Hospitalization for Bowel Obstruction  1  1/19 (5.26%) 
General disorders   
Hospitalization for Pain-Pelvis  1  1/19 (5.26%) 
Chest Pain  1  1/19 (5.26%) 
Pelvic Pain  1  1/19 (5.26%) 
Investigations   
Function Liver Tests  1  1/19 (5.26%) 
Renal and urinary disorders   
Urinary obstruction  1  1/19 (5.26%) 
Renal failure  1  1/19 (5.26%) 
Renal Obstruction  1  1/19 (5.26%) 
Hospitalization for Rectovaginal Fistula  1  2/19 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/19 (21.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   19/19 (100.00%) 
Blood and lymphatic system disorders   
Hemorrhage pulmonary Nose  1  4/19 (21.05%) 
Hemorrhage, GI Anus  1  1/19 (5.26%) 
Hemorrhage, GI Lower GI NOS  1  1/19 (5.26%) 
Hemorrhage, GI Oral cavity  1  1/19 (5.26%) 
Hemorrhage, GI Rectum  1  3/19 (15.79%) 
Hemorrhage, GU Bladder  1  2/19 (10.53%) 
Hemorrhage, GU Urinary NOS  1  2/19 (10.53%) 
Hemorrhage, GU Vagina  1  7/19 (36.84%) 
Edema: head and neck  1  4/19 (21.05%) 
Edema: limb  1  7/19 (36.84%) 
Edema: trunk/genital  1  2/19 (10.53%) 
Cardiac disorders   
Supraventricular arrhythmia Sinus tachycardia  1  1/19 (5.26%) 
Hypertension  1  10/19 (52.63%) 
Left ventricular systolic dysfunction  1  1/19 (5.26%) 
Pericardial effusion  1  2/19 (10.53%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  1  2/19 (10.53%) 
Endocrine disorders   
Hot flashes  1  4/19 (21.05%) 
Eye disorders   
Watery eye  1  1/19 (5.26%) 
Ocular - Other  1  1/19 (5.26%) 
Gastrointestinal disorders   
Anorexia  1  6/19 (31.58%) 
Ascites  1  1/19 (5.26%) 
Constipation  1  11/19 (57.89%) 
Diarrhea  1  15/19 (78.95%) 
Distension  1  4/19 (21.05%) 
Dry mouth  1  4/19 (21.05%) 
Enteritis  1  1/19 (5.26%) 
Fistula, GI Rectum  1  1/19 (5.26%) 
Fistula, GI Small bowel NOS  1  1/19 (5.26%) 
Gastritis  1  1/19 (5.26%) 
Heartburn  1  12/19 (63.16%) 
Hemorrhoids  1  2/19 (10.53%) 
Ileus  1  1/19 (5.26%) 
Mucositis (clinical exam) Oral cavity  1  10/19 (52.63%) 
Mucositis (functional/symptomatic) Oral cavity  1  1/19 (5.26%) 
Nausea  1  14/19 (73.68%) 
Taste alteration  1  10/19 (52.63%) 
Vomiting  1  10/19 (52.63%) 
GI - Other  1  6/19 (31.58%) 
General disorders   
Fatigue  1  17/19 (89.47%) 
Insomnia  1  8/19 (42.11%) 
Patient odor  1  1/19 (5.26%) 
Rigors/chills  1  3/19 (15.79%) 
Pain Abdomen NOS  1  10/19 (52.63%) 
Pain Back  1  10/19 (52.63%) 
Pain Bladder  1  1/19 (5.26%) 
Pain Bone  1  2/19 (10.53%) 
Pain Chest/thorax NOS  1  4/19 (21.05%) 
Pain Extremity-limb  1  5/19 (26.32%) 
Pain Head/headache  1  8/19 (42.11%) 
Pain Joint  1  2/19 (10.53%) 
Pain Lip  1  1/19 (5.26%) 
Pain Muscle  1  2/19 (10.53%) 
Pain Neck  1  1/19 (5.26%) 
Pain Oral cavity  1  2/19 (10.53%) 
Pain Pelvis  1  7/19 (36.84%) 
Pain Rectum  1  1/19 (5.26%) 
Pain Throat/pharynx/larynx  1  3/19 (15.79%) 
Pain Tumour pain  1  1/19 (5.26%) 
Pain Urethra  1  2/19 (10.53%) 
Pain Vagina  1  2/19 (10.53%) 
Infections and infestations   
Infection with normal ANC Abdomen NOS  1  1/19 (5.26%) 
Infection with normal ANC Bladder  1  1/19 (5.26%) 
Infection with normal ANC Dental-tooth  1  1/19 (5.26%) 
Infection with normal ANC Skin  1  1/19 (5.26%) 
Iinfection with normal ANC Urinary tract NOS  1  1/19 (5.26%) 
Infection with unknown ANC Bladder  1  1/19 (5.26%) 
Infection with unknown ANC Vagina  1  1/19 (5.26%) 
Opportunistic infection  1  1/19 (5.26%) 
Infection - Other  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/19 (5.26%) 
Muscle weakness Whole body/generalized  1  1/19 (5.26%) 
Nervous system disorders   
Dizziness  1  3/19 (15.79%) 
Mood alteration Agitation  1  1/19 (5.26%) 
Mood alteration Anxiety  1  3/19 (15.79%) 
Mood alteration Depression  1  1/19 (5.26%) 
Neuropathy-sensory  1  3/19 (15.79%) 
Renal and urinary disorders   
Bladder spasms  1  1/19 (5.26%) 
Fistula, GU Bladder  1  1/19 (5.26%) 
Fistula, GU Vagina  1  1/19 (5.26%) 
Leak, GU Urethra  1  1/19 (5.26%) 
Obstruction, GU Urethra  1  1/19 (5.26%) 
Renal failure  1  2/19 (10.53%) 
Urinary frequency  1  3/19 (15.79%) 
Reproductive system and breast disorders   
Vaginal discharge  1  5/19 (26.32%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/19 (5.26%) 
Cough  1  9/19 (47.37%) 
Dyspnea  1  9/19 (47.37%) 
Pleural effusion  1  1/19 (5.26%) 
Pneumonitis  1  2/19 (10.53%) 
Voice changes  1  1/19 (5.26%) 
Pulmonary - Other  1  2/19 (10.53%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  3/19 (15.79%) 
Bruising  1  2/19 (10.53%) 
Dry skin  1  4/19 (21.05%) 
Hand-foot  1  5/19 (26.32%) 
Hypopigmentation  1  3/19 (15.79%) 
Induration  1  2/19 (10.53%) 
Nail changes  1  1/19 (5.26%) 
Photosensitivity  1  1/19 (5.26%) 
Pruritus  1  2/19 (10.53%) 
Rash  1  8/19 (42.11%) 
Urticaria  1  1/19 (5.26%) 
Dermatology - Other (yellowing of the skin)  1  10/19 (52.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Helen Mackay
Organization: Princess Margaret Hospital, Toronto, Canada
Phone: (416) 946-2253
EMail: helen.mackay@uhn.ca
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00389974     History of Changes
Other Study ID Numbers: NCI-2014-00648
NCI-2014-00648 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCIC CTG IND.184
IND.184
NCIC-184 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-184 ( Other Identifier: CTEP )
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: February 4, 2015
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015