ClinicalTrials.gov
ClinicalTrials.gov Menu

Irinotecan Study For Cervical Cancer

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: NCT00136955
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : June 25, 2009
Last Update Posted : June 19, 2015
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uterine Cervical Neoplasms
Intervention Drug: Irinotecan
Enrollment 41
Recruitment Details  
Pre-assignment Details All 41 subjects had a primary diagnosis of squamous cell carcinoma of the cervix with a mean duration of 2.8 years (range: 0-12.9 years) since first diagnosis. No subject had a history of other cancer.
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Period Title: Overall Study
Started 41
Completed 18
Not Completed 23
Reason Not Completed
Adverse Event             8
Lost to Follow-up             1
Withdrawal by Subject             2
Incl. prog. disease, protocol violation             12
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
55.9  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Hide Description Tumor response according to RECIST.
Time Frame At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description:
Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participant
complete response (CR) 8
partial response (PR) 7
stable disease (SD) 11
progressive disease (PD) 6
not evaluable 0
missing 0
Response Rate (PR + CR) - naive 15
Response Rate (PR + CR) - corrected 15
2.Primary Outcome
Title Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Hide Description Tumor response according to RECIST.
Time Frame At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description:
Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participant
complete response 8
partial response 8
stable disease 13
progressive disease 8
not evaluable 4
missing 0
Response Rate (PR + CR) - naive 16
3.Secondary Outcome
Title Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
Hide Description TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Time Frame Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description:
Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: days
Overall Survival
652
(398 to 840)
Time to tumor progression
277
(157 to 682)
4.Secondary Outcome
Title Overall Survival (OS) and Time to Tumor Progression (ITT Population)
Hide Description TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Time Frame Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description:
Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
Overall Number of Participants Analyzed 41
Median (95% Confidence Interval)
Unit of Measure: days
Overall Survival
448
(348 to 680)
Time to Tumor Progression
263
(157 to 652)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Irinotecan/Cisplatin
Hide Arm/Group Description Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
All-Cause Mortality
Irinotecan/Cisplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Irinotecan/Cisplatin
Affected / at Risk (%)
Total   25 
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/41 (7.32%) 
Leukopenia   14/41 (34.15%) 
Gastrointestinal disorders   
Diarrhoea   6/41 (14.63%) 
Gastrointestinal disorder   1/41 (2.44%) 
Ileus   1/41 (2.44%) 
Nausea   5/41 (12.20%) 
Proctitis   1/41 (2.44%) 
Vomiting   5/41 (12.20%) 
General disorders   
Asthenia   4/41 (9.76%) 
Pyrexia   8/41 (19.51%) 
Infections and infestations   
Infection   10/41 (24.39%) 
Investigations   
Haemoglobin   9/41 (21.95%) 
Neutrophil count decreased   13/41 (31.71%) 
Platelet count   4/41 (9.76%) 
Weight decreased   1/41 (2.44%) 
Metabolism and nutrition disorders   
Anorexia   2/41 (4.88%) 
Hypercalcaemia   1/41 (2.44%) 
Hypokalaemia   1/41 (2.44%) 
Nervous system disorders   
Depressed level of consciousness   1/41 (2.44%) 
Syncope   1/41 (2.44%) 
Renal and urinary disorders   
Bladder pain   1/41 (2.44%) 
Urinary retention   1/41 (2.44%) 
Urogenital disorder   1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/41 (2.44%) 
Pleural effusion   1/41 (2.44%) 
Pneumonitis   1/41 (2.44%) 
Pneumothorax   1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
Skin disorder   1/41 (2.44%) 
Vascular disorders   
Hypotension   2/41 (4.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Irinotecan/Cisplatin
Affected / at Risk (%)
Total   40 
Blood and lymphatic system disorders   
Blood disorder   9/41 (21.95%) 
Leukopenia   24/41 (58.54%) 
Gastrointestinal disorders   
Abdominal pain   6/41 (14.63%) 
Constipation   7/41 (17.07%) 
Diarrhoea   26/41 (63.41%) 
Flatulence   3/41 (7.32%) 
Gastrointestinal disorder   3/41 (7.32%) 
Nausea   20/41 (48.78%) 
Vomiting   27/41 (65.85%) 
General disorders   
Asthenia   10/41 (24.39%) 
Oedema   3/41 (7.32%) 
Pain   10/41 (24.39%) 
Pyrexia   3/41 (7.32%) 
Infections and infestations   
Infection   11/41 (26.83%) 
Investigations   
Alanine aminotransferase increased   3/41 (7.32%) 
Aspartate aminotransferase increased   4/41 (9.76%) 
Haemoglobin   32/41 (78.05%) 
Neutrophil count decreased   16/41 (39.02%) 
Platelet count   15/41 (36.59%) 
Weight decreased   5/41 (12.20%) 
Metabolism and nutrition disorders   
Anorexia   10/41 (24.39%) 
Nervous system disorders   
Dizziness   4/41 (9.76%) 
Headache   3/41 (7.32%) 
Psychiatric disorders   
Insomnia   10/41 (24.39%) 
Renal and urinary disorders   
Micturition disorder   3/41 (7.32%) 
Renal failure   4/41 (9.76%) 
Urinary retention   3/41 (7.32%) 
Reproductive system and breast disorders   
Vaginal haemorrhage   4/41 (9.76%) 
Respiratory, thoracic and mediastinal disorders   
Cough   10/41 (24.39%) 
Skin and subcutaneous tissue disorders   
Alopecia   10/41 (24.39%) 
Exfoliative rash   4/41 (9.76%) 
Pruritus   3/41 (7.32%) 
Skin disorder   3/41 (7.32%) 
Surgical and medical procedures   
Packed red blood cell transfusion   5/41 (12.20%) 
Vascular disorders   
Hypertension   4/41 (9.76%) 
Indicates events were collected by systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00136955     History of Changes
Other Study ID Numbers: XRP4174/2502
A5961083
First Submitted: August 25, 2005
First Posted: August 29, 2005
Results First Submitted: May 7, 2009
Results First Posted: June 25, 2009
Last Update Posted: June 19, 2015