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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from local medical clinic from July 2009 through November 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Treatment (Cisplatin, Triapine, Radiation Therapy)
STARTED   26 
COMPLETED   25 
NOT COMPLETED   1 
Patient non-compliant                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline demographic characteristics include all 26 patients. Study specific characteristics only include the 25 patients that received treatment.

Reporting Groups
  Description
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.


Baseline Measures
   Treatment (Cisplatin, Triapine, Radiation Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age, Customized 
[Units: Participants]
 
30-39   1 
40-49   7 
50-59   11 
60-69   6 
70-79   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   7.7% 
Not Hispanic or Latino      24  92.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   26 
GOG Performance Status [1] 
[Units: Participants]
 
 23 
 2 
[1] 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] 
[Units: Participants]
 
Squamous cell carcinoma   23 
Adenosquamous carcinoma   1 
Adenocarcinoma   1 
[1] One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Tumor Grade [1] 
[Units: Participants]
 
Grade 2   13 
Grade 3   12 
[1] One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Cervical Stromal Invasion [1] 
[Units: Participants]
 
Less than 2/3rds invasion   3 
2/3rds or greater invasion   22 
[1] One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
Lymphovascular invasion [1] 
[Units: Participants]
 
Absent   7 
Present   18 
[1] 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] 
[Units: 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] One patient was non-compliant and received no therapy. Patient was excluded from study specific baseline characteristics.
HPV Genotyping [1] 
[Units: Participants]
 
HPV 16   15 
HPV 18   4 
HPV-naive   6 
[1] Cervical cancer genotyping


  Outcome Measures

1.  Primary:   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.   [ Time Frame: post therapy at 3 months ]

2.  Secondary:   Clinical and Objective Response Assignment   [ Time Frame: post therapy at 3 months ]

3.  Secondary:   Clinical and Objective Response Assignment   [ Time Frame: one month follow up assessment ]

4.  Secondary:   Clinical and Objective Response Assignment   [ Time Frame: three month follow up assessment ]

5.  Secondary:   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   [ Time Frame: After 5 weeks of radiation therapy ]

6.  Secondary:   Progression-free Survival   [ Time Frame: at 18 months from study entry ]

7.  Secondary:   PET/CT Scan Metabolic Activity   [ Time Frame: Baseline (pre-therapy) ]

8.  Secondary:   PET/CT Scan Metabolic Activity   [ Time Frame: 3 months post-treatment ]

9.  Secondary:   PET/CT Scan Metabolic Activity   [ Time Frame: Up to 5 years ]

10.  Secondary:   Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire   [ Time Frame: Baseline to up to 5 years ]

11.  Secondary:   Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling   [ Time Frame: 18 months from study entry ]

12.  Secondary:   Progression Free Survival by HPV Subtype   [ Time Frame: Baseline ]

13.  Post-Hoc:   Progression Free Survival by Smoking Status   [ Time Frame: at 18 months from study entry ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: kunosc@summahealth.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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