ClinicalTrials.gov
ClinicalTrials.gov Menu

Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, 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: NCT01026792
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : September 10, 2015
Last Update Posted : September 10, 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 Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IIIA Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions Drug: Temsirolimus
Other: Laboratory Biomarker Analysis
Enrollment 38

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 38
Completed 37
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
50
(26 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
37
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Objective Response Rate
Hide Description Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for response
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description:
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients with response
3
(0.1 to 15.8)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Temsirolimus)
Hide Arm/Group Description Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   15/37 (40.54%) 
Blood and lymphatic system disorders   
Anemia  1  2/37 (5.41%) 
Gastrointestinal disorders   
Mucositis oral  1  1/37 (2.70%) 
Abdominal pain  1  2/37 (5.41%) 
Diarrhea  1  1/37 (2.70%) 
Nausea  1  1/37 (2.70%) 
Vomiting  1  1/37 (2.70%) 
Upper gastrointestinal hemorrhage  1  1/37 (2.70%) 
Small intestinal obstruction  1  2/37 (5.41%) 
General disorders   
Edema: limb  1  2/37 (5.41%) 
Death NOS  1  6/37 (16.22%) 
Fatigue  1  1/37 (2.70%) 
Investigations   
Creatinine increased  1  1/37 (2.70%) 
Metabolism and nutrition disorders   
Dehydration  1  1/37 (2.70%) 
Hyponatremia  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/37 (2.70%) 
Nervous system disorders   
Paresthesia  1  1/37 (2.70%) 
Psychiatric disorders   
Depression  1  1/37 (2.70%) 
Renal and urinary disorders   
Hematuria  1  2/37 (5.41%) 
Other renal and urinary disorders  1  2/37 (5.41%) 
Urinary tract infection  1  2/37 (5.41%) 
Urinary tract obstruction  1  1/37 (2.70%) 
Reproductive system and breast disorders   
Female genital tract fistula  1  1/37 (2.70%) 
Pelvic pain  1  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/37 (2.70%) 
Pleural effusion  1  1/37 (2.70%) 
Bronchial obstruction  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/37 (2.70%) 
Vascular disorders   
Thromboembolic event  1  1/37 (2.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Temsirolimus)
Affected / at Risk (%)
Total   37/37 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  5/37 (13.51%) 
Cardiac disorders   
Palpitations  1  2/37 (5.41%) 
Ear and labyrinth disorders   
Other ear and labyrinth disorders  1  2/37 (5.41%) 
Endocrine disorders   
Hypothyroidism  1  3/37 (8.11%) 
Gastrointestinal disorders   
Abdominal pain  1  10/37 (27.03%) 
Bloating  1  3/37 (8.11%) 
Constipation  1  20/37 (54.05%) 
Diarrhea  1  15/37 (40.54%) 
Dry mouth  1  4/37 (10.81%) 
Dyspepsia  1  6/37 (16.22%) 
Dysphagia  1  3/37 (8.11%) 
Flatulence  1  4/37 (10.81%) 
Gastroesophageal reflux disease  1  3/37 (8.11%) 
Hemorrhoids  1  2/37 (5.41%) 
Mucositis oral  1  13/37 (35.14%) 
Nausea  1  20/37 (54.05%) 
Rectal hemorrhage  1  3/37 (8.11%) 
Vomiting  1  12/37 (32.43%) 
Other gastrointestinal disorders  1  13/37 (35.14%) 
General disorders   
Chills  1  4/37 (10.81%) 
Edema face  1  3/37 (8.11%) 
Edema limbs  1  15/37 (40.54%) 
Fatigue  1  30/37 (81.08%) 
Fever  1  4/37 (10.81%) 
Non-cardiac chest pain  1  2/37 (5.41%) 
Pain  1  9/37 (24.32%) 
Other general disorders, administration site conditions  1  2/37 (5.41%) 
Infections and infestations   
Urinary tract infection  1  7/37 (18.92%) 
Other infections and infestations  1  3/37 (8.11%) 
Injury, poisoning and procedural complications   
Bruising  1  4/37 (10.81%) 
Investigations   
Weight gain  1  3/37 (8.11%) 
Weight loss  1  3/37 (8.11%) 
Metabolism and nutrition disorders   
Anorexia  1  17/37 (45.95%) 
Dehydration  1  3/37 (8.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/37 (5.41%) 
Arthritis  1  2/37 (5.41%) 
Back pain  1  18/37 (48.65%) 
Chest wall pain  1  3/37 (8.11%) 
Flank pain  1  4/37 (10.81%) 
Muscle weakness lower limb  1  2/37 (5.41%) 
Myalgia  1  4/37 (10.81%) 
Neck pain  1  3/37 (8.11%) 
Pain in extremity  1  15/37 (40.54%) 
Other musculoskeletal and connective tissue disorder  1  5/37 (13.51%) 
Nervous system disorders   
Dizziness  1  3/37 (8.11%) 
Dysgeusia  1  5/37 (13.51%) 
Headache  1  13/37 (35.14%) 
Paresthesia  1  2/37 (5.41%) 
Peripheral sensory neuropathy  1  8/37 (21.62%) 
Somnolence  1  2/37 (5.41%) 
Psychiatric disorders   
Anxiety  1  4/37 (10.81%) 
Depression  1  4/37 (10.81%) 
Insomnia  1  18/37 (48.65%) 
Renal and urinary disorders   
Hematuria  1  5/37 (13.51%) 
Urinary frequency  1  7/37 (18.92%) 
Urinary tract obstruction  1  2/37 (5.41%) 
Urinary tract pain  1  4/37 (10.81%) 
Urinary urgency  1  2/37 (5.41%) 
Other renal and urinary disorders  1  5/37 (13.51%) 
Reproductive system and breast disorders   
Pelvic pain  1  5/37 (13.51%) 
Vaginal discharge  1  5/37 (13.51%) 
Vaginal hemorrhage  1  4/37 (10.81%) 
Other reproductive system and breast disorders  1  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/37 (24.32%) 
Dyspnea  1  9/37 (24.32%) 
Hoarseness  1  3/37 (8.11%) 
Pleural effusion  1  2/37 (5.41%) 
Productive cough  1  2/37 (5.41%) 
Sore throat  1  3/37 (8.11%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  3/37 (8.11%) 
Nail discoloration  1  2/37 (5.41%) 
Nail loss  1  3/37 (8.11%) 
Pain of skin  1  2/37 (5.41%) 
Pruritus  1  5/37 (13.51%) 
Rash acneiform  1  7/37 (18.92%) 
Rash maculo-papular  1  14/37 (37.84%) 
Skin ulceration  1  2/37 (5.41%) 
Other skin and subcutaneous tissue disorders  1  7/37 (18.92%) 
Vascular disorders   
Hot flashes  1  2/37 (5.41%) 
Hypertension  1  5/37 (13.51%) 
Lymphedema  1  4/37 (10.81%) 
Thromboembolic event  1  5/37 (13.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
Name/Title: Dr. Anna Tinker
Organization: BC Cancer Agency, Vancouver Clinic, Vancouver, BC, Canada
Phone: 604 877 6217
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01026792     History of Changes
Other Study ID Numbers: NCI-2014-00268
NCI-2014-00268 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCIC-CTG-199
CDR0000660702
IND.199
CAN-NCIC-IND199
NCIC-199 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-199 ( Other Identifier: CTEP )
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: July 6, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015