Trial Outcomes & Findings for Triapine, Cisplatin, and Radiation Therapy in Treating Patients With Cervical Cancer or Vaginal Cancer (NCT NCT00941070)

Last Updated: 2017-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

post therapy at 3 months

Results posted on

2017-11-17

Participant Flow

Patients were recruited from local medical clinic from July 2009 through November 2011

Participant milestones

Participant milestones
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) 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 Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) 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 Study Patient non-compliant	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=26 Participants 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.
Age, Customized 30-39	1 participants n=5 Participants
Age, Customized 40-49	7 participants n=5 Participants
Age, Customized 50-59	11 participants n=5 Participants
Age, Customized 60-69	6 participants n=5 Participants
Age, Customized 70-79	1 participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
GOG Performance Status 0	23 participants n=5 Participants
GOG Performance Status 1	2 participants n=5 Participants
Histopathology Squamous cell carcinoma	23 participants n=5 Participants
Histopathology Adenosquamous carcinoma	1 participants n=5 Participants
Histopathology Adenocarcinoma	1 participants n=5 Participants
Tumor Grade Grade 2	13 participants n=5 Participants
Tumor Grade Grade 3	12 participants n=5 Participants
Cervical Stromal Invasion Less than 2/3rds invasion	3 participants n=5 Participants
Cervical Stromal Invasion 2/3rds or greater invasion	22 participants n=5 Participants
Lymphovascular invasion Absent	7 participants n=5 Participants
Lymphovascular invasion Present	18 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IB2 Node Negative	1 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IB2 Node Positive	4 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IIA	4 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IIB	1 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IIIB	10 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Cervix IVB	2 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Vagina II	2 participants n=5 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Vagina IVA	1 participants n=5 Participants
HPV Genotyping HPV 16	15 participants n=5 Participants
HPV Genotyping HPV 18	4 participants n=5 Participants
HPV Genotyping HPV-naive	6 participants n=5 Participants

PRIMARY outcome

Timeframe: post therapy at 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=24 Participants 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.
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. Pretherapy SUV	14.6 Standard uptake value (SUV) Interval 12.1 to 17.7
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. Posttherapy SUV	2.6 Standard uptake value (SUV) Interval 2.0 to 3.4

SECONDARY outcome

Timeframe: post therapy at 3 months

Population: Patients that completed the 3-month F-18 FDG study.

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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
Clinical and Objective Response Assignment	21 participants

SECONDARY outcome

Timeframe: one month follow up assessment

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=24 Participants 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.
Clinical and Objective Response Assignment	23 participants

SECONDARY outcome

Timeframe: three month follow up assessment

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=24 Participants 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.
Clinical and Objective Response Assignment	23 participants

SECONDARY outcome

Timeframe: After 5 weeks of radiation therapy

Population: All patients who receive at least one dose of Triapine® and cisplatin treatment.

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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
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	0 percentage of patients

SECONDARY outcome

Timeframe: at 18 months from study entry

Population: Patients that completed the the 3-month 18F-FDG PET/CT.

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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
Progression-free Survival	67 percentage of patients Interval 56.0 to 78.0

SECONDARY outcome

Timeframe: Baseline (pre-therapy)

Population: Patients that completed the 3-month 18F-FDG PET/CT

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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
PET/CT Scan Metabolic Activity	14.6 Standard Uptake Value (SUV) Interval 12.1 to 17.7

SECONDARY outcome

Timeframe: 3 months post-treatment

Population: Patients that completed 3-month 18F-FDG PET/CT

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=24 Participants 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.
PET/CT Scan Metabolic Activity	2.6 Standard Uptake Value (SUV) Interval 2.0 to 3.4

SECONDARY outcome

Timeframe: Up to 5 years

Population: Data were not collected as the study was terminated prior to the time period for collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 5 years

Population: Data were not collected as the study was terminated prior to the time period for collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months from study entry

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling Non-Smokers	9 participants
Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling Smokers that quit while on study	11 participants
Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling Current smokers	5 participants

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
Progression Free Survival by HPV Subtype HPV16/18	74 percentage of patients Interval 63.0 to 85.0
Progression Free Survival by HPV Subtype HPV-naive tumors	83 percentage of patients Interval 62.0 to 98.0

POST_HOC outcome

Timeframe: at 18 months from study entry

Percent of patients that were progression free by smoking status

Outcome measures

Outcome measures
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 Participants 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.
Progression Free Survival by Smoking Status Non-Smokers	76 percentage of paticipants Interval 62.0 to 90.0
Progression Free Survival by Smoking Status Smokers that quit while on study	89 percentage of paticipants Interval 79.0 to 99.0
Progression Free Survival by Smoking Status Smokers	50 percentage of paticipants Interval 25.0 to 75.0

Adverse Events

Treatment (Cisplatin, Triapine, Radiation Therapy)

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 participants at risk 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.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • 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.
Investigations Alanine transaminase (ALT) increased	4.0% 1/25 • 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.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • 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.
Investigations Aspartate aminotransferase (AST) increased	4.0% 1/25 • 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.
Cardiac disorders Cardiac arrythmia- Atrial Fibrillation	4.0% 1/25 • 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.
Vascular disorders Deep Vein Thrombosis	8.0% 2/25 • 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.
Investigations Elevated alkaline phosphatase	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypernatremia	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypoalbuminemia	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypocalcemia	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypochloride	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypokalemia	16.0% 4/25 • 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.
Metabolism and nutrition disorders Hypomagnesemia	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • 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.
Vascular disorders Hypotension	4.0% 1/25 • 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.
Investigations INR-international normalized ratio increased	4.0% 1/25 • 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.
Investigations Leukocytopenia-white blood cell decrease	4.0% 1/25 • 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.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.0% 1/25 • 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.
Gastrointestinal disorders Mallory Weiss tears-upper gastrointestinal hemorrhage	4.0% 1/25 • 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.
Gastrointestinal disorders Nausea	4.0% 1/25 • 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.
Nervous system disorders Stroke	4.0% 1/25 • 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.
Investigations Thrombocytopenia-Platelet count decreased	8.0% 2/25 • 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.
Vascular disorders Thromboembolic event	4.0% 1/25 • 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.
Infections and infestations Urinary tract infection	4.0% 1/25 • 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.

Other adverse events

Other adverse events
Measure	Treatment (Cisplatin, Triapine, Radiation Therapy) n=25 participants at risk 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.
Gastrointestinal disorders Abdominal pain	12.0% 3/25 • 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.
Investigations Alanine transaminase (ALT) increased	24.0% 6/25 • 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.
Investigations Alkaline phosphatase increased	12.0% 3/25 • 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.
Blood and lymphatic system disorders Anemia	96.0% 24/25 • 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.
Metabolism and nutrition disorders Anorexia	12.0% 3/25 • 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.
Investigations Aspartate aminotransferase (AST) increased	12.0% 3/25 • 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.
General disorders Chest Pain (non-cardiac)	8.0% 2/25 • 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.
Gastrointestinal disorders Constipation	40.0% 10/25 • 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.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • 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.
Psychiatric disorders Depression	8.0% 2/25 • 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.
Gastrointestinal disorders Diarrhea	56.0% 14/25 • 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.
Nervous system disorders Dizziness	8.0% 2/25 • 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.
Nervous system disorders Dysgeusia	8.0% 2/25 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.0% 4/25 • 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.
Investigations Elevated GGT (gamma-Glutamyl transpeptidase)	24.0% 6/25 • 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.
Metabolism and nutrition disorders Elevated Lactate dehydrogenase (LDH)	12.0% 3/25 • 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.
Investigations Elevated creatinine	12.0% 3/25 • 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.
General disorders Fatigue	44.0% 11/25 • 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.
General disorders Fever	12.0% 3/25 • 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.
Gastrointestinal disorders GI reflux	8.0% 2/25 • 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.
Gastrointestinal disorders Heartburn (Dyspepsia)	28.0% 7/25 • 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.
Reproductive system and breast disorders Hemorrhage - vaginal	8.0% 2/25 • 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.
Metabolism and nutrition disorders Hypercalcemia	12.0% 3/25 • 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.
Metabolism and nutrition disorders Hyperglycemia	48.0% 12/25 • 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.
Metabolism and nutrition disorders Hypoalbuminemia	72.0% 18/25 • 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.
Metabolism and nutrition disorders Hypocalcemia	48.0% 12/25 • 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.
Metabolism and nutrition disorders Hypoglycemia	8.0% 2/25 • 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.
Metabolism and nutrition disorders Hypokalemia	40.0% 10/25 • 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.
Metabolism and nutrition disorders Hypomagnesemia	36.0% 9/25 • 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.
Metabolism and nutrition disorders Hyponatremia	56.0% 14/25 • 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.
Psychiatric disorders Insomnia	8.0% 2/25 • 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.
Investigations Leukocytopenia	56.0% 14/25 • 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.
Investigations Lymphocyte count decreased	8.0% 2/25 • 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.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • 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.
Gastrointestinal disorders Nausea	40.0% 10/25 • 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.
Investigations Neutropenia	28.0% 7/25 • 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.
Reproductive system and breast disorders Pelvic pain	20.0% 5/25 • 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.
General disorders Peripheral limb edema	16.0% 4/25 • 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.
Nervous system disorders Peripheral sensory neuropathy	16.0% 4/25 • 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.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.0% 2/25 • 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.
Skin and subcutaneous tissue disorders Skin Ulceration	8.0% 2/25 • 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.
Investigations Thrombocytopenia	76.0% 19/25 • 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.
Infections and infestations Urinary tract infection	16.0% 4/25 • 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.
Gastrointestinal disorders Vomiting	20.0% 5/25 • 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.
Investigations Weight loss	8.0% 2/25 • 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.

Additional Information

Dr. Charles Kunos

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 330-375-4485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60