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Trial record 7 of 197 for:    Vaginal Cancer: Clinical Trials

Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer

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ClinicalTrials.gov Identifier: NCT00941070
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : May 13, 2013
Last Update Posted : November 17, 2017
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 Recurrent Cervical Cancer
Recurrent Vaginal Cancer
Stage IB Cervical Cancer
Stage II Vaginal Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Vaginal Cancer
Stage IVA Cervical Cancer
Stage IVA Vaginal Cancer
Stage IVB Cervical Cancer
Stage IVB Vaginal Cancer
Therapy-related Toxicity
Interventions Drug: triapine
Drug: cisplatin
Radiation: external beam radiation therapy
Procedure: quality-of-life assessment
Other: questionnaire administration
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: computed tomography
Enrollment 26
Recruitment Details Patients were recruited from local medical clinic from July 2009 through November 2011
Pre-assignment Details  
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Period Title: Overall Study
Started 26
Completed 25
Not Completed 1
Reason Not Completed
Patient non-compliant             1
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
Baseline demographic characteristics include all 26 patients. Study specific characteristics only include the 25 patients that received treatment.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
30-39 1
40-49 7
50-59 11
60-69 6
70-79 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
26
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
2
   7.7%
Not Hispanic or Latino
24
  92.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  26.9%
White
18
  69.2%
More than one race
1
   3.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
GOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
0 23
1 2
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics. The Gynecologic Oncology Group (GOG) performance status reflects individual daily living activities on a scale of 0 (fully active with symptoms) to 5 (dead).
Histopathology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Squamous cell carcinoma 23
Adenosquamous carcinoma 1
Adenocarcinoma 1
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Tumor Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Grade 2 13
Grade 3 12
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Cervical Stromal Invasion   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Less than 2/3rds invasion 3
2/3rds or greater invasion 22
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Lymphovascular invasion   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Absent 7
Present 18
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
International Federation of Gynecology and Obstetrics (FIGO) Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Cervix IB2 Node Negative 1
Cervix IB2 Node Positive 4
Cervix IIA 4
Cervix IIB 1
Cervix IIIB 10
Cervix IVB 2
Vagina II 2
Vagina IVA 1
[1]
Measure Description: One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
HPV Genotyping   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
HPV 16 15
HPV 18 4
HPV-naive 6
[1]
Measure Description: Cervical cancer genotyping
1.Primary Outcome
Title Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.
Hide Description To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.
Time Frame post therapy at 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 24
Median (Inter-Quartile Range)
Unit of Measure: Standard uptake value (SUV)
Pretherapy SUV
14.6
(12.1 to 17.7)
Posttherapy SUV
2.6
(2.0 to 3.4)
2.Secondary Outcome
Title Clinical and Objective Response Assignment
Hide Description Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.
Time Frame post therapy at 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the 3-month F-18 FDG study.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
21
3.Secondary Outcome
Title Clinical and Objective Response Assignment
Hide Description Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.
Time Frame one month follow up assessment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
23
4.Secondary Outcome
Title Clinical and Objective Response Assignment
Hide Description Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.
Time Frame three month follow up assessment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
23
5.Secondary Outcome
Title Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011
Hide Description Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity.
Time Frame After 5 weeks of radiation therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who receive at least one dose of Triapine® and cisplatin treatment.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of patients
0
6.Secondary Outcome
Title Progression-free Survival
Hide Description Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier.
Time Frame at 18 months from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the the 3-month 18F-FDG PET/CT.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
67
(56 to 78)
7.Secondary Outcome
Title PET/CT Scan Metabolic Activity
Hide Description Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.
Time Frame Baseline (pre-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed the 3-month 18F-FDG PET/CT
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Median (Inter-Quartile Range)
Unit of Measure: Standard Uptake Value (SUV)
14.6
(12.1 to 17.7)
8.Secondary Outcome
Title PET/CT Scan Metabolic Activity
Hide Description Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.
Time Frame 3 months post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that completed 3-month 18F-FDG PET/CT
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 24
Median (Inter-Quartile Range)
Unit of Measure: Standard Uptake Value (SUV)
2.6
(2.0 to 3.4)
9.Secondary Outcome
Title PET/CT Scan Metabolic Activity
Hide Description Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected as the study was terminated prior to the time period for collection.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire
Hide Description [Not Specified]
Time Frame Baseline to up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected as the study was terminated prior to the time period for collection.
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling
Hide Description [Not Specified]
Time Frame 18 months from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Non-Smokers 9
Smokers that quit while on study 11
Current smokers 5
12.Secondary Outcome
Title Progression Free Survival by HPV Subtype
Hide Description Tabular descriptive data will be presented. HPV sub-type will be associated with treatment related toxicity, clinical response, PET metabolic response, and overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation will be used. Tests of equivalence of the estimates will be compared using the Wilcoxon long-rank test using a threshold for statistical significance of P 0.05. Cox proportional hazards regression models will be used in multivariate analyses.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
HPV16/18
74
(63 to 85)
HPV-naive tumors
83
(62 to 98)
13.Post-Hoc Outcome
Title Progression Free Survival by Smoking Status
Hide Description Percent of patients that were progression free by smoking status
Time Frame at 18 months from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description:

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of paticipants
Non-Smokers
76
(62 to 90)
Smokers that quit while on study
89
(79 to 99)
Smokers
50
(25 to 75)
Time Frame Adverse events were collected while patients were on treatment through the 6 month follow up visit. This occurred over a 3 year period that patients were on study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Cisplatin, Triapine, Radiation Therapy)
Hide Arm/Group Description

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

All-Cause Mortality
Treatment (Cisplatin, Triapine, Radiation Therapy)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Cisplatin, Triapine, Radiation Therapy)
Affected / at Risk (%)
Total   9/25 (36.00%) 
Blood and lymphatic system disorders   
Anemia * 1  1/25 (4.00%) 
Cardiac disorders   
Cardiac arrythmia- Atrial Fibrillation * 1  1/25 (4.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/25 (4.00%) 
Lower gastrointestinal hemorrhage * 1 [1]  1/25 (4.00%) 
Mallory Weiss tears-upper gastrointestinal hemorrhage * 1  1/25 (4.00%) 
Nausea * 1  1/25 (4.00%) 
Infections and infestations   
Urinary tract infection * 1  1/25 (4.00%) 
Investigations   
Alanine transaminase (ALT) increased * 1  1/25 (4.00%) 
Aspartate aminotransferase (AST) increased * 1  1/25 (4.00%) 
Elevated alkaline phosphatase * 1  1/25 (4.00%) 
INR-international normalized ratio increased * 1  1/25 (4.00%) 
Leukocytopenia-white blood cell decrease * 1  1/25 (4.00%) 
Thrombocytopenia-Platelet count decreased * 1  2/25 (8.00%) 
Metabolism and nutrition disorders   
Hypernatremia * 1  1/25 (4.00%) 
Hypoalbuminemia * 1  1/25 (4.00%) 
Hypocalcemia * 1  1/25 (4.00%) 
Hypochloride * 1  1/25 (4.00%) 
Hypokalemia * 1  4/25 (16.00%) 
Hypomagnesemia * 1  1/25 (4.00%) 
Hyponatremia * 1  1/25 (4.00%) 
Nervous system disorders   
Stroke * 1  1/25 (4.00%) 
Vascular disorders   
Deep Vein Thrombosis * 1  2/25 (8.00%) 
Hypotension * 1  1/25 (4.00%) 
Thromboembolic event * 1  1/25 (4.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Mallory-Weiss Tears
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Cisplatin, Triapine, Radiation Therapy)
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  24/25 (96.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  3/25 (12.00%) 
Constipation * 1  10/25 (40.00%) 
Diarrhea * 1  14/25 (56.00%) 
GI reflux * 1  2/25 (8.00%) 
Heartburn (Dyspepsia) * 1  7/25 (28.00%) 
Nausea * 1  10/25 (40.00%) 
Vomiting * 1  5/25 (20.00%) 
General disorders   
Chest Pain (non-cardiac) * 1  2/25 (8.00%) 
Fatigue * 1  11/25 (44.00%) 
Fever * 1  3/25 (12.00%) 
Peripheral limb edema * 1  4/25 (16.00%) 
Infections and infestations   
Urinary tract infection * 1  4/25 (16.00%) 
Investigations   
Alanine transaminase (ALT) increased * 1  6/25 (24.00%) 
Alkaline phosphatase increased * 1  3/25 (12.00%) 
Aspartate aminotransferase (AST) increased * 1  3/25 (12.00%) 
Elevated GGT (gamma-Glutamyl transpeptidase) * 1  6/25 (24.00%) 
Elevated creatinine * 1  3/25 (12.00%) 
Leukocytopenia * 1  14/25 (56.00%) 
Lymphocyte count decreased * 1  2/25 (8.00%) 
Neutropenia * 1  7/25 (28.00%) 
Thrombocytopenia * 1  19/25 (76.00%) 
Weight loss * 1  2/25 (8.00%) 
Metabolism and nutrition disorders   
Anorexia * 1  3/25 (12.00%) 
Elevated Lactate dehydrogenase (LDH) * 1  3/25 (12.00%) 
Hypercalcemia * 1  3/25 (12.00%) 
Hyperglycemia * 1  12/25 (48.00%) 
Hypoalbuminemia * 1  18/25 (72.00%) 
Hypocalcemia * 1  12/25 (48.00%) 
Hypoglycemia * 1  2/25 (8.00%) 
Hypokalemia * 1  10/25 (40.00%) 
Hypomagnesemia * 1  9/25 (36.00%) 
Hyponatremia * 1  14/25 (56.00%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  2/25 (8.00%) 
Nervous system disorders   
Dizziness * 1  2/25 (8.00%) 
Dysgeusia * 1  2/25 (8.00%) 
Peripheral sensory neuropathy * 1  4/25 (16.00%) 
Psychiatric disorders   
Depression * 1  2/25 (8.00%) 
Insomnia * 1  2/25 (8.00%) 
Reproductive system and breast disorders   
Hemorrhage - vaginal * 1  2/25 (8.00%) 
Pelvic pain * 1  5/25 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/25 (8.00%) 
Dyspnea * 1  4/25 (16.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular * 1  2/25 (8.00%) 
Skin Ulceration * 1  2/25 (8.00%) 
*
Indicates events were collected by non-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. Charles Kunos
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 330-375-4485
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00941070     History of Changes
Other Study ID Numbers: NCI-2012-02896
NCI-2012-02896 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000647544
CASE 11808 ( Other Identifier: Case Comprehensive Cancer Center )
8327 ( Other Identifier: CTEP )
P30CA043703 ( U.S. NIH Grant/Contract )
U01CA062502 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2009
First Posted: July 17, 2009
Results First Submitted: March 20, 2013
Results First Posted: May 13, 2013
Last Update Posted: November 17, 2017