Trial · NCT02595879
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
NCT02595879, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer. Trials, record NCT02595879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02595879
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
- NCT number
- NCT02595879
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma, Advanced Cervical Squamous Cell Carcinoma, Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7
- Interventions
Biospecimen Collection, Brachytherapy, Cisplatin, Computed Tomography, External Beam Radiation Therapy, Fludeoxyglucose F-18, High-Dose Rate Brachytherapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Pharmacological Study, Positron Emission Tomography, Triapine
- First posted
- 2015-11-04
- Last updated
- 2026-10-30
- Results first posted
- 2024-10-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | Up to 5 weeks | The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD |
| Primary | Number of Patients Who Experienced a DLT | Up to 5 weeks | Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver |
| Primary | Bioavailability of Triapine | Up to 2 weeks | The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry. |
| Primary | Cmax | Up to 24 hours after dosing | Maximum concentration |
| Primary | Tmax | Up to 24 hours after dosing | Time to maximum concentration, |
| Primary | AUC | Up to 24 hours after dosing | Area Under the Concentration-Time Curve (AUC 0-last) |
| Primary | Elimination Half-life (t 1/2) | Up to 24 hours after dosing | |
| Secondary | Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate | At 3 months post-treatment | The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool). |
| Secondary | Clinical Overall Response Rate | 3 months post-treatment | Clinical response at the recommended phase 2 dose per RECIST v1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Progression Free Survival (PFS) | Up to 4 years and 2 months from start of treatment | Median number of months that patients survive without disease progression from end of treatment. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) | Up to 5 weeks | All treated patients evaluable for DLTs | mg | NUMBER |
| PRIMARY | Number of Patients Who Experienced a DLT | Up to 5 weeks | All treated patients evaluable for DLTs | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Bioavailability of Triapine | Up to 2 weeks | Patients that had both PO and IV triapine PK samples | percentage | GEOMETRIC_MEAN |
| PRIMARY | Cmax | Up to 24 hours after dosing | Treated patients for whom PK samples were able to be collected | ug/L | GEOMETRIC_MEAN |
| PRIMARY | Tmax | Up to 24 hours after dosing | Treated patients for whom samples were able to be collected | hours | GEOMETRIC_MEAN |
| PRIMARY | AUC | Up to 24 hours after dosing | Treated patients for whom samples were able to be collected | ug/L x h | GEOMETRIC_MEAN |
| PRIMARY | Elimination Half-life (t 1/2) | Up to 24 hours after dosing | Treated patients for whom PK samples were able to be collected | hours | GEOMETRIC_MEAN |
| SECONDARY | Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate | At 3 months post-treatment | Patients who received at least 3 weeks of therapy (cisplatin + triapine), and had their disease re-evaluated with a 3-month post treatment 18F-FDG-PET/CT | percentage response-evaluable patients | NUMBER |
| SECONDARY | Clinical Overall Response Rate | 3 months post-treatment | Patients who received at least 3 weeks of therapy (cisplatin + triapine) and have had their disease re-evaluated (with a 3 month post treatment PET-CT) will be considered evaluable for response. (Note: Patients who exhibit objective disease progression prior to the end of cycle 1 will also be considered evaluable.) | percentage response evaluable patient | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Up to 4 years and 2 months from start of treatment | Treated patients evaluable for clinical response. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) | All Participants | 100 | mg | ||
| Number of Patients Who Experienced a DLT | Triapine (100mg) + Chemoradiation) | 1 | Participants | ||
| Number of Patients Who Experienced a DLT | Triapine (150mg) + Chemoradiation) | 2 | Participants | ||
| Bioavailability of Triapine | Triapine (100mg) + Chemoradiation) | 60 | 95% Confidence Interval 16 to 229 | percentage | |
| Bioavailability of Triapine | Triapine (150mg) + Chemoradiation) | 54 | 95% Confidence Interval 15 to 200 | percentage | |
| Cmax | Triapine (100mg) + Chemoradiation) | 476 | Standard Deviation 1.90 | ug/L | |
| Cmax | Triapine (150mg) + Chemoradiation) | 344 | Standard Deviation 1.91 | ug/L | |
| Tmax | Triapine (100mg) + Chemoradiation) | 0.9 | Standard Deviation 3.0 | hours | |
| Tmax | Triapine (150mg) + Chemoradiation) | 1.5 | Standard Deviation 1.5 | hours | |
| AUC | Triapine (100mg) + Chemoradiation) | 990 | Standard Deviation 2.09 | ug/L x h |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 / Dose Level 1 | STARTED | 100 mg PO Triapine + Chemoradiation | 3 | |
| Cohort 1 / Dose Level 1 | STARTED | 150 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 1 / Dose Level 1 | COMPLETED | 100 mg PO Triapine + Chemoradiation | 3 | |
| Cohort 1 / Dose Level 1 | COMPLETED | 150 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 1 / Dose Level 1 | NOT COMPLETED | 100 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 1 / Dose Level 1 | NOT COMPLETED | 150 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 2 / Dose Level 2 | STARTED | 100 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 2 / Dose Level 2 | STARTED | 150 mg PO Triapine + Chemoradiation | 4 | |
| Cohort 2 / Dose Level 2 | COMPLETED | 100 mg PO Triapine + Chemoradiation | 0 | |
| Cohort 2 / Dose Level 2 | COMPLETED | 150 mg PO Triapine + Chemoradiation | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events254
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Triapine (100mg) + Chemoradiation) | 16 | 17 | |
| other | Anemia | Blood and lymphatic system disorders | Triapine (150mg) + Chemoradiation) | 3 | 4 | |
| other | Blood bicarbonate decreased | Blood and lymphatic system disorders | Triapine (100mg) + Chemoradiation) | 1 | 17 | |
| other | Blood bicarbonate decreased | Blood and lymphatic system disorders | Triapine (150mg) + Chemoradiation) | 0 | 4 | |
| other | Decreased platelets | Blood and lymphatic system disorders | Triapine (100mg) + Chemoradiation) | 13 | 17 | |
| other | Decreased platelets | Blood and lymphatic system disorders | Triapine (150mg) + Chemoradiation) | 3 | 4 | |
| other | Luekocytosis | Blood and lymphatic system disorders | Triapine (100mg) + Chemoradiation) | 1 | 17 | |
| other | Luekocytosis | Blood and lymphatic system disorders | Triapine (150mg) + Chemoradiation) | 0 | 4 | |
| other | Chest pain - cardiac | Cardiac disorders | Triapine (100mg) + Chemoradiation) | 1 | 17 | |
| other | Chest pain - cardiac | Cardiac disorders | Triapine (150mg) + Chemoradiation) | 2 | 4 |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triapine (100mg) + Chemoradiation) | 0 | 17 |
| Total, all-cause mortality | Triapine (150mg) + Chemoradiation) | 0 | 4 |
| Total, other adverse events | Triapine (100mg) + Chemoradiation) | 17 | 17 |
| Total, other adverse events | Triapine (150mg) + Chemoradiation) | 4 | 4 |
| Total, serious adverse events | Triapine (100mg) + Chemoradiation) | 8 | 17 |
| Total, serious adverse events | Triapine (150mg) + Chemoradiation) | 2 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39673591 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186690 | NCI ETCTN Pittsburgh Cancer Consortium (PCC) | VILLARUZ, LIZA COSCA; BYRD, JOHN C.; DAYYANI, FARSHID | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Triapine (100mg) + Chemoradiation) vs Triapine (150mg) + Chemoradiation): Number of Patients Who Experienced a DLT | Trial comparisons |
| Triapine (100mg) + Chemoradiation) vs Triapine (150mg) + Chemoradiation): deaths from any cause | Trial comparisons |
| Triapine (100mg) + Chemoradiation) vs Triapine (150mg) + Chemoradiation): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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