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NCT02466971 · REGISTRY CONDITION SEARCH

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-21

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS) Rate at 3 Years

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outcome · POSTED

Progression-free Survival (PFS) Rate at 3 Years

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outcome · POSTED

Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period

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outcome · NOT POSTED

Number of Participants With Hematologic Toxicity During Treatment Period

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outcome · NOT POSTED

Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period

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outcome · NOT POSTED

Peripheral Blood Methemoglobin

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outcome · NOT POSTED

Metabolic Complete Response (mCR)

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outcome · NOT POSTED

Intensity Modulated Radiation Therapy (IG-IMRT)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patient has a new, unrated histologic diagnosis of stage IB2 (\> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan * Patient must provide study specific informed consent prior to study entry * Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent * Absolute neutrophil count \> 1,500/uL * Platelets \> 100,000/uL * Hemoglobin \> 10 g/dL * Total bilirubin \< 2.0 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 X institutional upper limit of normal * Prothrombin time (PT)/activated partial thromboplastin time (aPTT) \< 1.5 X institutional upper limit of normal * Creatinine =\< 1.5 mg/dL to receive weekly cisplatin * Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is \>= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used * Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose \> 200 mg/dL) * Patient has a life expectancy of greater than 20 weeks * Patient does not have known brain metastases (testing optional) * Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine * Patient does not have a known allergy to compounds of similar or biologic composition as triapine * Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional) * Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy) Exclusion Criteria: * Patient has another concurrent active invasive malignancy * Patient has had a prior invasive malignancy diagnosed within the last three years (except \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician * Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine \> 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements * Patient is receiving another investigational agent for the treatment of cancer * Patient is currently pregnant * Patient does not agree to use two forms of birth control if they are of child-bearing potential * Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017) * Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017) * Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017) * Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Radiation: Brachytherapy
    2. Drug: Cisplatin
    3. Radiation: External Beam Radiation Therapy
    4. Radiation: Intensity-Modulated Radiation Therapy
    5. Other: Laboratory Biomarker Analysis
    6. Radiation: Radiation Therapy
    label
    Arm I (cisplatin, IMRT or RT, brachytherapy)
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Radiation: Brachytherapy
    2. Drug: Cisplatin
    3. Radiation: Intensity-Modulated Radiation Therapy
    4. Other: Laboratory Biomarker Analysis
    5. Radiation: Radiation Therapy
    6. Drug: Triapine
    label
    Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    2. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Undergo brachytherapy
    name
    Brachytherapy
    other Names
    1. Brachytherapy, NOS
    2. Internal Radiation
    3. Internal Radiation Brachytherapy
    4. Internal Radiation Therapy
    5. Radiation Brachytherapy
    6. Radiation, Internal
    type
    RADIATION
  2. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    2. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    description
    Undergo EBRT
    name
    External Beam Radiation Therapy
    other Names
    1. Definitive Radiation Therapy
    2. EBRT
    3. External Beam Radiation
    4. External Beam Radiotherapy
    5. External Beam Radiotherapy (conventional)
    6. External Beam RT
    7. external radiation
    8. External Radiation Therapy
    9. external-beam radiation
    10. Radiation, External Beam
    11. Teleradiotherapy
    12. Teletherapy
    type
    RADIATION
  4. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    2. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Undergo IMRT
    name
    Intensity-Modulated Radiation Therapy
    other Names
    1. IMRT
    2. Intensity modulated radiation therapy (procedure)
    3. Intensity Modulated RT
    4. Intensity-Modulated Radiotherapy
    5. Radiation, Intensity-Modulated Radiotherapy
    type
    RADIATION
  5. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    2. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  6. arm Group Labels
    1. Arm I (cisplatin, IMRT or RT, brachytherapy)
    2. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Undergo conventional RT
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. Energy Type
    3. ENERGY_TYPE
    4. Irradiate
    5. Irradiated
    6. Irradiation
    7. Radiation
    8. Radiation Therapy, NOS
    9. Radiotherapeutics
    10. Radiotherapy
    11. RT
    12. Therapy, Radiation
    type
    RADIATION
  7. arm Group Labels
    1. Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
    description
    Given IV
    name
    Triapine
    other Names
    1. 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
    2. 3-AP
    3. 3-Apct
    4. OCX-0191
    5. OCX-191
    6. OCX191
    7. PAN-811
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
450
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Number of participants with hematologic toxicity during treatment period, where hematologic toxicity is defined as occurrence of any grade 3 or higher adverse events for neutropenia, leukopenia, lymphopenia, anemia, or thrombocytopenia. Adverse events are graded and categorized using CTCAE v4.0.
    measure
    Number of Participants With Hematologic Toxicity During Treatment Period
    time Frame
    Up to 30 days after completion of study treatment
  2. description
    Number of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0.
    measure
    Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period
    time Frame
    Up to 5 years
  3. description
    Peripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II.
    measure
    Peripheral Blood Methemoglobin
    time Frame
    Baseline to 24 hours after triapine infusion
  4. description
    The assessment of metabolic complete response is based on the ratio of post 3-month therapy PET/CT maximum standardized update value (SUV) to pre-therapy PET/CT maximum SUV. The metabolic complete response is classified as complete response for a ratio of 0.33 or less, or partial response for a ratio between 0.34 and 0.75, or stable response for a ratio greater that 0.75 but less than 1.25, or progressive response for a ratio greater than 1.25.
    measure
    Metabolic Complete Response (mCR)
    time Frame
    Up to 3 months after completion of treatment
  5. description
    Number of Participants with KBP IG-IMRT
    measure
    Intensity Modulated Radiation Therapy (IG-IMRT)
    time Frame
    Up to 60 days.
primary Outcomes
  1. description
    Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
    measure
    Overall Survival (OS) Rate at 3 Years
    time Frame
    At 3 years from randomization.
secondary Outcomes
  1. description
    Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol.
    measure
    Progression-free Survival (PFS) Rate at 3 Years
    time Frame
    At 3 years from study randomization.
  2. description
    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
    measure
    Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period
    time Frame
    During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.
Full study description
brief Summary
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.
detailed Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer. SECONDARY OBJECTIVE: I. To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. TERTIARY OBJECTIVES: I. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) II. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v\]4.0) by treatment arm and by radiation modality. (05/30/2017) III. To summarize and compare differences in chronic or late (\>= 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) IV. To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients). V. To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using normal tissue complication probability (NTCP) models, and determine whether KBP should be a requirement for future IG-IMRT protocols. VI. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) PET/CT metabolic complete response rate by treatment arm VII. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. positron emission tomography (PET)/computed tomography (CT)-based IG-IMRT vs. conventional radiation therapy (RT), and assess the impact of treatment on changes in hematopoietic compensatory response. VIII. To develop and validate machine learning and radiomics techniques for dose accumulation, automated treatment planning, and prediction of treatment response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo external beam radiation therapy (EBRT) (either conventional RT or intensity modulated radiation therapy \[IMRT\]) once daily (QD) 5 days a week for 25 fractions followed by low dose rate (LDR) or high dose rate (HDR) brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, and then every 6 months for 3 years. The patient data from NCI #9434 will be merged with NRG-GY006 per the Protocol Analysis Plan.
Source references
references
  1. citation
    Kunos CA, Andrews SJ, Moore KN, Chon HS, Ivy SP. Randomized Phase II Trial of Triapine-Cisplatin-Radiotherapy for Locally Advanced Stage Uterine Cervix or Vaginal Cancers. Front Oncol. 2019 Oct 15;9:1067. doi: 10.3389/fonc.2019.01067. eCollection 2019.
    pmid
    31681600
    type
    DERIVED
  2. citation
    Kunos CA, Ivy SP. Triapine Radiochemotherapy in Advanced Stage Cervical Cancer. Front Oncol. 2018 May 7;8:149. doi: 10.3389/fonc.2018.00149. eCollection 2018.
    pmid
    29868473
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice