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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00262821
Recruitment Status : Terminated (Study drug no longer available resulting in lack of study drug for participants.)
First Posted : December 7, 2005
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Interventions Drug: cisplatin
Drug: tirapazamine
Enrollment 402
Recruitment Details  
Pre-assignment Details Eligible and evaluable patients.
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Hide Arm/Group Description Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Period Title: Overall Study
Started 198 204
Completed 194 185
Not Completed 4 19
Reason Not Completed
Ineligible - wrong stage             0             3
Ineligible - wrong cell type             2             2
Ineligible - wrong primary             0             1
Ineligible - inadequate pathology             1             3
Ineligible - elevated creatinine             0             2
Ineligible - required test not done             1             4
Inevaluable - inadequate data             0             4
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation Total
Hide Arm/Group Description Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium Total of all reporting groups
Overall Number of Baseline Participants 194 185 379
Hide Baseline Analysis Population Description
Eligible and evaluable patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 185 participants 379 participants
48.9  (11.3) 48.4  (11.3) 48.7  (11.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
20-30 years 7 10 17
31-40 years 41 37 78
41-50 years 65 61 126
51-60 years 53 48 101
61-70 years 20 23 43
71-79 years 8 6 14
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
Female
194
 100.0%
185
 100.0%
379
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
Hispanic or Latino
20
  10.3%
24
  13.0%
44
  11.6%
Not Hispanic or Latino
161
  83.0%
138
  74.6%
299
  78.9%
Unknown or Not Reported
13
   6.7%
23
  12.4%
36
   9.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
American Indian or Alaska Native
8
   4.1%
2
   1.1%
10
   2.6%
Asian
6
   3.1%
10
   5.4%
16
   4.2%
Native Hawaiian or Other Pacific Islander
1
   0.5%
2
   1.1%
3
   0.8%
Black or African American
43
  22.2%
30
  16.2%
73
  19.3%
White
129
  66.5%
134
  72.4%
263
  69.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   3.6%
7
   3.8%
14
   3.7%
Gynecologic Oncology Group (GOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
0 – fully active 147 141 288
1 – restricted strenuous activity, ambulatory 46 41 87
2 – ambulatory, difficulty walking 1 2 3
3 – limited self-care, partly confined to bed 0 1 1
4 – completely disabled, no self-care 0 0 0
[1]
Measure Description: 5-point, ordinal scale specifying patient's ability to perform activities
Tumor Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
1 – Well differentiated 8 12 20
2 – Moderately differentiated 105 103 208
3 – Poorly differentiated 78 67 145
Not graded 3 3 6
[1]
Measure Description: Tumor grade was obtained from the central GOG Pathology Committee review
International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcin   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
IB 33 32 65
IIA 11 12 23
IIB 93 82 175
IIIB 51 52 103
IVA 6 7 13
[1]
Measure Description: International Federation of Gynecologic and Obstetrics (FIGO), Clinical Staging, for Cervical Carcinoma (1995). Stage IB is defined as clinical lesions confined to the cervix or pre-clinical lesions greater than stage 1A. Stage IIA is defined as the carcinoma extends beyond the cervix but has not extended on to the pelvic wall with no obvious parametrial involvement. Stage IIB has obvious parametrial involvement. Stage IIIB includes extension on to the pelvic wall and/or hydro-nephrosis or non-functioning kidney. Stage IVA is the spread of the growth to adjacent organs.
Histologic Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
Squamous cell carcinoma 164 158 322
Adenocarcinoma, unspecified 15 18 33
Adenosquamous carcinoma 11 5 16
Other 4 4 8
[1]
Measure Description: Histologic (cell) type was obtained from the central GOG Pathology Committee review
Para-aortic Lymph Node  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
Not sampled 25 33 58
Sampled 169 152 321
Brachytherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
None 4 5 9
Low-dose rate 52 51 103
High-dose rate 138 129 267
Cooperative Group Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 185 participants 379 participants
Gynecologic Oncology Group (GOG) 167 167 334
National Cancer Institute of Canada (NCIC) 24 17 41
Other 3 1 4
1.Primary Outcome
Title Progression-free Survival - Percentage of Patients Alive and Progression Free
Hide Description Patients’ progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.
Time Frame From study entry until first disease progression, death or date of last contact, up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Hide Arm/Group Description:
Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Number of Participants Analyzed 194 185
Measure Type: Number
Unit of Measure: percentage of patients
64.4 63.0
2.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or date of last contact.
Time Frame From study entry to death or last contact, up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Hide Arm/Group Description:
Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Number of Participants Analyzed 194 185
Measure Type: Number
Unit of Measure: percentage of patients alive
70.6 70.5
3.Secondary Outcome
Title Adverse Events (Grade 3 or Higher) During Treatment Period
Hide Description Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Time Frame All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Treated Patients
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Hide Arm/Group Description:
Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
Overall Number of Participants Analyzed 190 180
Measure Type: Number
Unit of Measure: participants
Number Participants Analyzed 190 180
Leukopenia 51 53
Thrombocytopenia 8 6
Neutropenia 30 26
Anemia 16 12
Other hematologic 20 17
Allergy/Immunology 0 2
Cardiac 3 4
Coagulation 0 1
Constitutional 15 23
Dermatologic 0 17
Gastrointestinal 28 35
Genitourinary/Renal 4 4
Hemorrhage 5 5
Infection 14 14
Metabolic 28 45
Musculoskeletal 0 5
Neuropathy 1 1
Other Neurological 5 14
Pain 10 38
Pulmonary 3 6
Vascular Disorders 11 7
Death, Not CTC Coded 4 0
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Adverse Event Reporting Description Incidence of SAE among eligible and evaluable, treated patients.
 
Arm/Group Title Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Hide Arm/Group Description Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
All-Cause Mortality
Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   42/190 (22.11%)   65/180 (36.11%) 
Blood and lymphatic system disorders     
Neutrophils * 1  0/190 (0.00%)  1/180 (0.56%) 
Platelets * 1  0/190 (0.00%)  1/180 (0.56%) 
Leukocytes * 1  2/190 (1.05%)  1/180 (0.56%) 
Lymphopenia * 1  5/190 (2.63%)  4/180 (2.22%) 
Hemoglobin * 1  2/190 (1.05%)  1/180 (0.56%) 
Cardiac disorders     
S/N Arrhythmia: Sinus Bradycardia * 1  0/190 (0.00%)  1/180 (0.56%) 
Ventricular Arrhythmia - Fibrillation * 1  0/190 (0.00%)  1/180 (0.56%) 
Cardiac General - Other * 1  0/190 (0.00%)  1/180 (0.56%) 
Ear and labyrinth disorders     
Hearing (Without Monitoring Program) * 1  0/190 (0.00%)  1/180 (0.56%) 
Gastrointestinal disorders     
Obstruction, Gi - Ileum * 1  1/190 (0.53%)  0/180 (0.00%) 
Ulcer,gi - Esophagus * 1  0/190 (0.00%)  1/180 (0.56%) 
Distention * 1  0/190 (0.00%)  1/180 (0.56%) 
Obstruction, Gi - Small Bowel Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
Colitis * 1  0/190 (0.00%)  1/180 (0.56%) 
Vomiting * 1  3/190 (1.58%)  5/180 (2.78%) 
Anorexia * 1  0/190 (0.00%)  1/180 (0.56%) 
Dehydration * 1  3/190 (1.58%)  3/180 (1.67%) 
Nausea * 1  0/190 (0.00%)  2/180 (1.11%) 
Stricture, Gi - Rectum * 1  0/190 (0.00%)  1/180 (0.56%) 
Diarrhea * 1  1/190 (0.53%)  5/180 (2.78%) 
General disorders     
Fever * 1  1/190 (0.53%)  1/180 (0.56%) 
Fatigue * 1  2/190 (1.05%)  0/180 (0.00%) 
Death No Ctcae Term - Death Nos * 1  2/190 (1.05%)  0/180 (0.00%) 
Death No Ctcae Term - Multi-Organ Failure * 1  1/190 (0.53%)  0/180 (0.00%) 
Pain - Other * 1  1/190 (0.53%)  1/180 (0.56%) 
Pain: Pelvis * 1  0/190 (0.00%)  2/180 (1.11%) 
Pain: Chest /Thorax Nos * 1  1/190 (0.53%)  1/180 (0.56%) 
Pain: Back * 1  0/190 (0.00%)  1/180 (0.56%) 
Pain: Abdominal Pain Nos * 1  1/190 (0.53%)  2/180 (1.11%) 
Pain: Cardiac/ Heart * 1  0/190 (0.00%)  1/180 (0.56%) 
Pain: Muscle * 1  0/190 (0.00%)  1/180 (0.56%) 
Hepatobiliary disorders     
Liver Dysfunction * 1  0/190 (0.00%)  1/180 (0.56%) 
Immune system disorders     
Allergic Reaction/Hypersensitivity * 1  0/190 (0.00%)  1/180 (0.56%) 
Infections and infestations     
Inf W/Gr 3 Or 4 Anc: Blood * 1  2/190 (1.05%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  1/190 (0.53%)  0/180 (0.00%) 
Febrile Neutropenia * 1  2/190 (1.05%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
Infection - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf Unknown Anc: Rectum * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  1/190 (0.53%)  2/180 (1.11%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  0/190 (0.00%)  1/180 (0.56%) 
Metabolism and nutrition disorders     
Metabolic/Laboratory - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Creatinine * 1  0/190 (0.00%)  3/180 (1.67%) 
Alt * 1  0/190 (0.00%)  2/180 (1.11%) 
Hypocalcemia * 1  0/190 (0.00%)  1/180 (0.56%) 
Hyperglycemia * 1  0/190 (0.00%)  1/180 (0.56%) 
Hypokalemia * 1  1/190 (0.53%)  2/180 (1.11%) 
Nervous system disorders     
Syncope * 1  0/190 (0.00%)  1/180 (0.56%) 
Mood Alteration - Depression * 1  1/190 (0.53%)  2/180 (1.11%) 
Mood Alteration - Anxiety * 1  0/190 (0.00%)  2/180 (1.11%) 
Cognitive Disturbance * 1  0/190 (0.00%)  1/180 (0.56%) 
Renal and urinary disorders     
Renal/Genitourinary - Other * 1  0/190 (0.00%)  1/180 (0.56%) 
Obstruction, Gu - Ureter * 1  1/190 (0.53%)  0/180 (0.00%) 
Renal Failure * 1  1/190 (0.53%)  0/180 (0.00%) 
Urinary Frequency * 1  0/190 (0.00%)  1/180 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Ards * 1  0/190 (0.00%)  1/180 (0.56%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/190 (0.00%)  2/180 (1.11%) 
Vascular disorders     
Hemorrhage, Gu - Vagina * 1  2/190 (1.05%)  2/180 (1.11%) 
Hemorrhage, Gu - Uterus * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage, Gu - Bladder * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage/Bleeding - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Vascular - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Artery Injury - Aorta * 1  0/190 (0.00%)  1/180 (0.56%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  0/190 (0.00%)  1/180 (0.56%) 
Thrombosis/Thrombus/Embolism * 1  8/190 (4.21%)  4/180 (2.22%) 
*
Indicates events were collected by non-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 0%
Concurrent Cisplatin and Radiation Concurrent Cisplatin, Tirapazamine and Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   187/190 (98.42%)   179/180 (99.44%) 
Blood and lymphatic system disorders     
Neutrophils * 1  86/190 (45.26%)  78/180 (43.33%) 
Platelets * 1  73/190 (38.42%)  66/180 (36.67%) 
Blood/Bone Marrow - Other * 1  6/190 (3.16%)  6/180 (3.33%) 
Leukocytes * 1  139/190 (73.16%)  128/180 (71.11%) 
Lymphopenia * 1  21/190 (11.05%)  16/180 (8.89%) 
Hemoglobin * 1  153/190 (80.53%)  135/180 (75.00%) 
Edema: Trunk/Genital * 1  0/190 (0.00%)  2/180 (1.11%) 
Edema: Limb * 1  12/190 (6.32%)  13/180 (7.22%) 
Edema: Head And Neck * 1  0/190 (0.00%)  2/180 (1.11%) 
Cardiac disorders     
S/N Arrhythmia: Atrial Fibrillation * 1  0/190 (0.00%)  1/180 (0.56%) 
Palpitations * 1  2/190 (1.05%)  2/180 (1.11%) 
Ventricular Arrhythmia - Tachycardia * 1  1/190 (0.53%)  1/180 (0.56%) 
Supraventricular Extrasystoles * 1  0/190 (0.00%)  1/180 (0.56%) 
S/N Arrhythmia: Sinus Tachycardia * 1  2/190 (1.05%)  4/180 (2.22%) 
Supraventricular Tachycardia * 1  1/190 (0.53%)  0/180 (0.00%) 
S/N Arrhythmia:supraventricular Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
S/N Arrhythmia: Sinus Bradycardia * 1  1/190 (0.53%)  0/180 (0.00%) 
Ventricular Arrhythmia - Pvcs * 1  0/190 (0.00%)  1/180 (0.56%) 
Ventricular Arrhythmia - Trigeminny * 1  0/190 (0.00%)  1/180 (0.56%) 
S/N Arrhythmia: Atrial Tachycardia * 1  1/190 (0.53%)  0/180 (0.00%) 
Cardiac Ischemia/Infarction * 1  1/190 (0.53%)  1/180 (0.56%) 
Hypertension * 1  10/190 (5.26%)  5/180 (2.78%) 
Cardiac General - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Cardiac Troponin T (Ctnt) * 1  0/190 (0.00%)  1/180 (0.56%) 
Hypotension * 1  2/190 (1.05%)  5/180 (2.78%) 
Ear and labyrinth disorders     
Auditory/Ear - Other * 1  3/190 (1.58%)  2/180 (1.11%) 
Hearing (Without Monitoring Program) * 1  1/190 (0.53%)  4/180 (2.22%) 
Tinnitus * 1  22/190 (11.58%)  25/180 (13.89%) 
Hearing (Monitoring Program) * 1  2/190 (1.05%)  0/180 (0.00%) 
Endocrine disorders     
Hot Flashes * 1  21/190 (11.05%)  12/180 (6.67%) 
Eye disorders     
Ocular/Visual - Other * 1  0/190 (0.00%)  3/180 (1.67%) 
Dry Eye * 1  1/190 (0.53%)  2/180 (1.11%) 
Photophobia * 1  0/190 (0.00%)  1/180 (0.56%) 
Flashing Lights/Floaters * 1  1/190 (0.53%)  5/180 (2.78%) 
Diplopia * 1  2/190 (1.05%)  0/180 (0.00%) 
Blurred Vision * 1  6/190 (3.16%)  11/180 (6.11%) 
Gastrointestinal disorders     
Enteritis * 1  1/190 (0.53%)  0/180 (0.00%) 
Obstruction, Gi - Ileum * 1  0/190 (0.00%)  1/180 (0.56%) 
Proctitis * 1  2/190 (1.05%)  1/180 (0.56%) 
Flatulence * 1  3/190 (1.58%)  2/180 (1.11%) 
Gastritis * 1  0/190 (0.00%)  1/180 (0.56%) 
Esophagitis * 1  4/190 (2.11%)  3/180 (1.67%) 
Hemorrhoids * 1  7/190 (3.68%)  2/180 (1.11%) 
Heartburn * 1  19/190 (10.00%)  13/180 (7.22%) 
Perforation, Gi - Rectum * 1  0/190 (0.00%)  1/180 (0.56%) 
Ileus * 1  1/190 (0.53%)  0/180 (0.00%) 
Dysphagia * 1  0/190 (0.00%)  3/180 (1.67%) 
Distention * 1  1/190 (0.53%)  1/180 (0.56%) 
Taste Alteration * 1  28/190 (14.74%)  27/180 (15.00%) 
Incontinence, Anal * 1  1/190 (0.53%)  2/180 (1.11%) 
Dry Mouth * 1  4/190 (2.11%)  8/180 (4.44%) 
Mucositis (Functional/Sympt) - Rectum * 1  1/190 (0.53%)  0/180 (0.00%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  3/190 (1.58%)  9/180 (5.00%) 
Obstruction, Gi - Small Bowel Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
Colitis * 1  1/190 (0.53%)  1/180 (0.56%) 
Necrosis, Gi - Rectum * 1  0/190 (0.00%)  1/180 (0.56%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  8/190 (4.21%)  10/180 (5.56%) 
Vomiting * 1  75/190 (39.47%)  107/180 (59.44%) 
Anorexia * 1  59/190 (31.05%)  60/180 (33.33%) 
Dehydration * 1  7/190 (3.68%)  19/180 (10.56%) 
Constipation * 1  50/190 (26.32%)  47/180 (26.11%) 
Nausea * 1  127/190 (66.84%)  134/180 (74.44%) 
Gastrointestinal - Other * 1  6/190 (3.16%)  3/180 (1.67%) 
Diarrhea * 1  119/190 (62.63%)  112/180 (62.22%) 
General disorders     
Constitutional Symptoms - Other * 1  2/190 (1.05%)  2/180 (1.11%) 
Sweating * 1  6/190 (3.16%)  3/180 (1.67%) 
Weight Gain * 1  1/190 (0.53%)  1/180 (0.56%) 
Fever * 1  12/190 (6.32%)  10/180 (5.56%) 
Weight Loss * 1  35/190 (18.42%)  43/180 (23.89%) 
Rigors/Chills * 1  2/190 (1.05%)  3/180 (1.67%) 
Fatigue * 1  140/190 (73.68%)  134/180 (74.44%) 
Insomnia * 1  22/190 (11.58%)  21/180 (11.67%) 
Pain - Other * 1  9/190 (4.74%)  12/180 (6.67%) 
Pain: Urethra * 1  6/190 (3.16%)  10/180 (5.56%) 
Pain: Perineum * 1  0/190 (0.00%)  1/180 (0.56%) 
Pain: Pelvis * 1  27/190 (14.21%)  28/180 (15.56%) 
Pain: Vagina * 1  11/190 (5.79%)  6/180 (3.33%) 
Pain: Uterus * 1  1/190 (0.53%)  0/180 (0.00%) 
Pain: Chest /Thorax Nos * 1  0/190 (0.00%)  6/180 (3.33%) 
Pain: Chest Wall * 1  3/190 (1.58%)  0/180 (0.00%) 
Pain: Throat/Pharynx/Larynx * 1  2/190 (1.05%)  1/180 (0.56%) 
Pain: Head/Headache * 1  25/190 (13.16%)  15/180 (8.33%) 
Pain: Neck * 1  2/190 (1.05%)  0/180 (0.00%) 
Pain: Extremity-Limb * 1  13/190 (6.84%)  28/180 (15.56%) 
Pain: Buttock * 1  1/190 (0.53%)  2/180 (1.11%) 
Pain: Back * 1  23/190 (12.11%)  21/180 (11.67%) 
Pain: Joint * 1  6/190 (3.16%)  2/180 (1.11%) 
Pain: Bone * 1  4/190 (2.11%)  2/180 (1.11%) 
Pain: Kidney * 1  0/190 (0.00%)  2/180 (1.11%) 
Pain: Bladder * 1  9/190 (4.74%)  7/180 (3.89%) 
Pain: Pain Nos * 1  5/190 (2.63%)  1/180 (0.56%) 
Pain: Stomach * 1  3/190 (1.58%)  3/180 (1.67%) 
Pain: Rectum * 1  5/190 (2.63%)  7/180 (3.89%) 
Pain: Peritoneum * 1  1/190 (0.53%)  0/180 (0.00%) 
Pain: Oral Cavity * 1  1/190 (0.53%)  0/180 (0.00%) 
Pain: Esophagus * 1  0/190 (0.00%)  1/180 (0.56%) 
Pain: Dental/Teeth/Peridontal * 1  0/190 (0.00%)  1/180 (0.56%) 
Pain: Abdominal Pain Nos * 1  52/190 (27.37%)  36/180 (20.00%) 
Pain: Cardiac/ Heart * 1  1/190 (0.53%)  1/180 (0.56%) 
Pain: Tumor * 1  3/190 (1.58%)  1/180 (0.56%) 
Pain: Muscle * 1  12/190 (6.32%)  48/180 (26.67%) 
Pain: Anus * 1  1/190 (0.53%)  1/180 (0.56%) 
Pain: Neuralgia * 1  1/190 (0.53%)  0/180 (0.00%) 
Syndromes - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Hepatobiliary disorders     
Hepatobiliary/Pancreas - Other * 1  0/190 (0.00%)  1/180 (0.56%) 
Immune system disorders     
Allergy/Immunology - Other * 1  0/190 (0.00%)  1/180 (0.56%) 
Allergic Reaction/Hypersensitivity * 1  4/190 (2.11%)  6/180 (3.33%) 
Rhinitis * 1  3/190 (1.58%)  4/180 (2.22%) 
Infections and infestations     
Inf W/Gr 3 Or 4 Anc: Blood * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Artery * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Cervix * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  1/190 (0.53%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  2/190 (1.05%)  0/180 (0.00%) 
Febrile Neutropenia * 1  0/190 (0.00%)  2/180 (1.11%) 
Inf Unknown Anc: Nerve-Peripheral * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  10/190 (5.26%)  15/180 (8.33%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
Infection - Other * 1  0/190 (0.00%)  3/180 (1.67%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) * 1  1/190 (0.53%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx * 1  0/190 (0.00%)  2/180 (1.11%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  2/190 (1.05%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf Unknown Anc: Bronchus * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf Unknown Anc: Urinary Tract Nos * 1  4/190 (2.11%)  0/180 (0.00%) 
Inf Unknown Anc: Bladder (Urinary) * 1  1/190 (0.53%)  1/180 (0.56%) 
Inf Unknown Anc: Rectum * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) * 1  1/190 (0.53%)  0/180 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  0/190 (0.00%)  1/180 (0.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  2/190 (1.05%)  6/180 (3.33%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  3/190 (1.58%)  0/180 (0.00%) 
Metabolism and nutrition disorders     
Ast * 1  4/190 (2.11%)  20/180 (11.11%) 
Gfr * 1  3/190 (1.58%)  4/180 (2.22%) 
Metabolic/Laboratory - Other * 1  4/190 (2.11%)  8/180 (4.44%) 
Proteinuria * 1  1/190 (0.53%)  0/180 (0.00%) 
Creatinine * 1  22/190 (11.58%)  21/180 (11.67%) 
Hypoalbuminemia * 1  22/190 (11.58%)  37/180 (20.56%) 
Ggt * 1  5/190 (2.63%)  7/180 (3.89%) 
Alt * 1  6/190 (3.16%)  27/180 (15.00%) 
Alkaline Phosphatase * 1  8/190 (4.21%)  17/180 (9.44%) 
Bilirubin * 1  5/190 (2.63%)  5/180 (2.78%) 
Lipase * 1  1/190 (0.53%)  0/180 (0.00%) 
Hypermagnesemia * 1  4/190 (2.11%)  3/180 (1.67%) 
Hypophosphatemia * 1  4/190 (2.11%)  6/180 (3.33%) 
Hyponatremia * 1  40/190 (21.05%)  46/180 (25.56%) 
Hyperuricemia * 1  0/190 (0.00%)  1/180 (0.56%) 
Bicarbonate, Serum-Low * 1  4/190 (2.11%)  3/180 (1.67%) 
Amylase * 1  1/190 (0.53%)  0/180 (0.00%) 
Acidosis * 1  1/190 (0.53%)  0/180 (0.00%) 
Hypernatremia * 1  2/190 (1.05%)  5/180 (2.78%) 
Hypocalcemia * 1  32/190 (16.84%)  37/180 (20.56%) 
Hyperkalemia * 1  7/190 (3.68%)  7/180 (3.89%) 
Hyperglycemia * 1  46/190 (24.21%)  61/180 (33.89%) 
Hypokalemia * 1  40/190 (21.05%)  61/180 (33.89%) 
Hypoglycemia * 1  8/190 (4.21%)  1/180 (0.56%) 
Hypercalcemia * 1  3/190 (1.58%)  3/180 (1.67%) 
Hypomagnesemia * 1  52/190 (27.37%)  51/180 (28.33%) 
Musculoskeletal and connective tissue disorders     
Myositis * 1  1/190 (0.53%)  0/180 (0.00%) 
Musculoskeletal/St: Other * 1  4/190 (2.11%)  14/180 (7.78%) 
Osteoporosis * 1  1/190 (0.53%)  0/180 (0.00%) 
Joint-Function * 1  3/190 (1.58%)  0/180 (0.00%) 
Arthritis * 1  3/190 (1.58%)  0/180 (0.00%) 
Muscle Weakness - Whole Body/Generalized * 1  10/190 (5.26%)  6/180 (3.33%) 
Muscle Weakness - Extremity-Lower * 1  2/190 (1.05%)  1/180 (0.56%) 
Nervous system disorders     
Neuropathy,cranial - Cn X Motor-Palate * 1  1/190 (0.53%)  1/180 (0.56%) 
Syncope * 1  0/190 (0.00%)  4/180 (2.22%) 
Involuntary Movement * 1  1/190 (0.53%)  0/180 (0.00%) 
Psychosis * 1  1/190 (0.53%)  0/180 (0.00%) 
Neurology - Other * 1  3/190 (1.58%)  2/180 (1.11%) 
Encephalopathy * 1  0/190 (0.00%)  1/180 (0.56%) 
Mood Alteration - Depression * 1  18/190 (9.47%)  12/180 (6.67%) 
Mood Alteration - Anxiety * 1  15/190 (7.89%)  18/180 (10.00%) 
Mood Alteration - Agitation * 1  0/190 (0.00%)  3/180 (1.67%) 
Tremor * 1  2/190 (1.05%)  2/180 (1.11%) 
Personality * 1  0/190 (0.00%)  1/180 (0.56%) 
Somnolence * 1  0/190 (0.00%)  1/180 (0.56%) 
Confusion * 1  2/190 (1.05%)  4/180 (2.22%) 
Memory Impairment * 1  2/190 (1.05%)  3/180 (1.67%) 
Dizziness * 1  20/190 (10.53%)  22/180 (12.22%) 
Neuropathy,cranial - Cn I Smell * 1  1/190 (0.53%)  2/180 (1.11%) 
Neuropathy-Sensory * 1  31/190 (16.32%)  30/180 (16.67%) 
Neuropathy-Motor * 1  1/190 (0.53%)  12/180 (6.67%) 
Renal and urinary disorders     
Renal/Genitourinary - Other * 1  3/190 (1.58%)  2/180 (1.11%) 
Stricture, Anastomotic, Gu - Urethra * 1  1/190 (0.53%)  0/180 (0.00%) 
Stricture, Anastomotic, Gu - Ureter * 1  1/190 (0.53%)  0/180 (0.00%) 
Leak, Gu - Vagina * 1  1/190 (0.53%)  0/180 (0.00%) 
Cystitis * 1  27/190 (14.21%)  17/180 (9.44%) 
Urinary Color Change * 1  1/190 (0.53%)  2/180 (1.11%) 
Urinary Retention * 1  1/190 (0.53%)  4/180 (2.22%) 
Obstruction, Gu - Urethra * 1  1/190 (0.53%)  0/180 (0.00%) 
Obstruction, Gu - Ureter * 1  3/190 (1.58%)  1/180 (0.56%) 
Obstruction, Gu - Bladder * 1  0/190 (0.00%)  1/180 (0.56%) 
Incontinence, Urinary * 1  6/190 (3.16%)  4/180 (2.22%) 
Fistula, Gu - Vagina * 1  2/190 (1.05%)  0/180 (0.00%) 
Bladder Spasm * 1  12/190 (6.32%)  8/180 (4.44%) 
Renal Failure * 1  0/190 (0.00%)  1/180 (0.56%) 
Urinary Frequency * 1  28/190 (14.74%)  13/180 (7.22%) 
Reproductive system and breast disorders     
Vaginal Dryness * 1  0/190 (0.00%)  2/180 (1.11%) 
Sexual/Reproductive Function: Other * 1  1/190 (0.53%)  1/180 (0.56%) 
Vaginal Discharge * 1  30/190 (15.79%)  14/180 (7.78%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary: Other * 1  0/190 (0.00%)  2/180 (1.11%) 
Bronchospasm * 1  1/190 (0.53%)  1/180 (0.56%) 
Voice Changes * 1  0/190 (0.00%)  1/180 (0.56%) 
Hypoxia * 1  1/190 (0.53%)  1/180 (0.56%) 
Hiccoughs * 1  1/190 (0.53%)  0/180 (0.00%) 
Cough * 1  11/190 (5.79%)  8/180 (4.44%) 
Pleural Effusion * 1  0/190 (0.00%)  1/180 (0.56%) 
Dyspnea * 1  15/190 (7.89%)  15/180 (8.33%) 
Skin and subcutaneous tissue disorders     
Nail Changes * 1  4/190 (2.11%)  0/180 (0.00%) 
Injection Site Reaction * 1  2/190 (1.05%)  3/180 (1.67%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  12/190 (6.32%)  14/180 (7.78%) 
Erythema Multiforme * 1  1/190 (0.53%)  3/180 (1.67%) 
Dermatitis - Chemoradiation * 1  1/190 (0.53%)  0/180 (0.00%) 
Wound Complication, Non-Infectious * 1  0/190 (0.00%)  1/180 (0.56%) 
Bruising * 1  3/190 (1.58%)  2/180 (1.11%) 
Acne * 1  2/190 (1.05%)  0/180 (0.00%) 
Rash * 1  12/190 (6.32%)  43/180 (23.89%) 
Dry Skin * 1  1/190 (0.53%)  6/180 (3.33%) 
Decubitus * 1  0/190 (0.00%)  2/180 (1.11%) 
Dermatitis - Radiation * 1  26/190 (13.68%)  23/180 (12.78%) 
Pruritus * 1  6/190 (3.16%)  13/180 (7.22%) 
Burn * 1  0/190 (0.00%)  1/180 (0.56%) 
Urticaria * 1  0/190 (0.00%)  1/180 (0.56%) 
Flushing * 1  2/190 (1.05%)  1/180 (0.56%) 
Dermatology/Skin - Other * 1  5/190 (2.63%)  7/180 (3.89%) 
Hyperpigmentation * 1  4/190 (2.11%)  8/180 (4.44%) 
Vascular disorders     
Inr * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage, Gu - Urinary Nos * 1  3/190 (1.58%)  1/180 (0.56%) 
Hemorrhage, Gu - Vagina * 1  39/190 (20.53%)  28/180 (15.56%) 
Hemorrhage, Gi - Rectum * 1  2/190 (1.05%)  3/180 (1.67%) 
Hemorrhage/Pulmonary - Nose * 1  1/190 (0.53%)  1/180 (0.56%) 
Hematoma * 1  1/190 (0.53%)  0/180 (0.00%) 
Hemorrhage, Gi - Anus * 1  1/190 (0.53%)  0/180 (0.00%) 
Hemorrhage, Gu - Uterus * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage, Gi - Oral Cavity * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage, Gu - Kidney * 1  0/190 (0.00%)  1/180 (0.56%) 
Hemorrhage, Gu - Bladder * 1  2/190 (1.05%)  1/180 (0.56%) 
Petechiae * 1  1/190 (0.53%)  0/180 (0.00%) 
Hemorrhage/Bleeding - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Vascular - Other * 1  1/190 (0.53%)  0/180 (0.00%) 
Vein Injury - Extremity-Upper * 1  1/190 (0.53%)  0/180 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  0/190 (0.00%)  2/180 (1.11%) 
Thrombosis/Thrombus/Embolism * 1  3/190 (1.58%)  2/180 (1.11%) 
Phlebitis * 1  0/190 (0.00%)  1/180 (0.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Premature closure due to lack of study drug leading to small number of subjects analyzed.
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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262821     History of Changes
Obsolete Identifiers: NCT00704873
Other Study ID Numbers: NCI-2009-00591
NCI-2009-00591 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CAN-NCIC-GOG-0219
CDR0000455555
GOG-0219 ( Other Identifier: Gynecologic Oncology Group )
GOG-0219 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: October 9, 2015
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017