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NCT02595879 · REGISTRY CONDITION SEARCH

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

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

Phase
PHASE1
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-07-31

This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.

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

Maximum Tolerated Dose (MTD)

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outcome · POSTED

Number of Patients Who Experienced a DLT

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outcome · POSTED

Bioavailability of Triapine

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outcome · POSTED

Cmax

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outcome · POSTED

Tmax

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outcome · POSTED

AUC

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outcome · POSTED

Elimination Half-life (t 1/2)

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outcome · POSTED

Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate

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outcome · POSTED

Clinical Overall Response Rate

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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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, untreated histologic diagnosis of stage IB2 (\> 5 cm), II, IIIB, IIIC or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan * Age \>= 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Life expectancy greater than 6 months * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin (Hgb) \>= 10.0 g/dL (blood transfusions to reach this amount are allowed) * Serum creatinine =\< 1.5 mg/dL to receive weekly cisplatin * If serum creatinine is between 1.5 and 1.9 mg/dL, patients 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) * Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with known Gilbert syndrome, a total bilirubin =\< 3.0 x ULN, with direct bilirubin =\< 1.5 x ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN * Able to take oral medication * Not pregnant and not breastfeeding; the effects of triapine on the developing human fetus are unknown; for this reason as well as because heterocyclic carboxaldehydethiosemicarbazones and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patient must have documented negative urine pregnancy test must be resulted within 7 days before initiating protocol therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine; these potential risks may also apply to other agents used in this study * For HIV and hepatitis B/C (HEPB/C): * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for the dose escalation portion of this trial; for those patients who are enrolled in the HIV positive (+) expansion cohort, they must be HIV infected and be on retroviral therapy with an undetectable viral load within 6 months of enrollment * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured; for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Able to understand and willingness to sign a written informed consent document Exclusion Criteria: * 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 * Patients receiving any other investigational agents * Patients with known glucose-6-phosphate dehydrogenase deficiency (G6PD) are excluded due to an inability to administer the antidote for methemoglobinemia, methylene blue; pre-registration testing for G6PD is at the investigator's discretion and is not required for study enrollment * Patients who are taking any medication associated with methemoglobinemia; medication must be discontinued and must have a washout period of 4 halflives or 4 weeks, whichever is shorter * History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or cisplatin * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements * Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =\< 200 mg/dL allowed) * 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 * Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation
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 undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Radiation: Brachytherapy
    3. Drug: Cisplatin
    4. Procedure: Computed Tomography
    5. Radiation: External Beam Radiation Therapy
    6. Other: Fludeoxyglucose F-18
    7. Radiation: High-Dose Rate Brachytherapy
    8. Radiation: Intensity-Modulated Radiation Therapy
    9. Procedure: Magnetic Resonance Imaging
    10. Other: Pharmacological Study
    11. Procedure: Positron Emission Tomography
    12. Drug: Triapine
    label
    Treatment (triapine, chemoradiation)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo collection of blood samples
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Sample Collection
    4. Specimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo LDR 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
  3. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    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
  4. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo FDG-PET/CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  5. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo pelvic 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
  6. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo FDG-PET/CT
    name
    Fludeoxyglucose F-18
    other Names
    1. 18FDG
    2. FDG
    3. Fludeoxyglucose (18F)
    4. fludeoxyglucose F 18
    5. Fludeoxyglucose F18
    6. Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    7. Fluorodeoxyglucose F18
    type
    OTHER
  7. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo HDR brachytherapy
    name
    High-Dose Rate Brachytherapy
    other Names
    1. Brachytherapy, High Dose
    2. HDR
    3. High dose brachytherapy (procedure)
    type
    RADIATION
  8. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    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
  9. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  10. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Correlative studies
    name
    Pharmacological Study
    type
    OTHER
  11. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Undergo FDG-PET/CT
    name
    Positron Emission Tomography
    other Names
    1. Medical Imaging, Positron Emission Tomography
    2. PET
    3. PET Scan
    4. Positron emission tomography (procedure)
    5. Positron Emission Tomography Scan
    6. Positron-Emission Tomography
    7. PT
    type
    PROCEDURE
  12. arm Group Labels
    1. Treatment (triapine, chemoradiation)
    description
    Given IV and PO
    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
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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
    measure
    Maximum Tolerated Dose (MTD)
    time Frame
    Up to 5 weeks
  2. description
    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
    measure
    Number of Patients Who Experienced a DLT
    time Frame
    Up to 5 weeks
  3. description
    The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.
    measure
    Bioavailability of Triapine
    time Frame
    Up to 2 weeks
  4. description
    Maximum concentration
    measure
    Cmax
    time Frame
    Up to 24 hours after dosing
  5. description
    Time to maximum concentration,
    measure
    Tmax
    time Frame
    Up to 24 hours after dosing
  6. description
    Area Under the Concentration-Time Curve (AUC 0-last)
    measure
    AUC
    time Frame
    Up to 24 hours after dosing
  7. measure
    Elimination Half-life (t 1/2)
    time Frame
    Up to 24 hours after dosing
secondary Outcomes
  1. description
    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).
    measure
    Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate
    time Frame
    At 3 months post-treatment
  2. description
    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.
    measure
    Clinical Overall Response Rate
    time Frame
    3 months post-treatment
  3. description
    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).
    measure
    Progression Free Survival (PFS)
    time Frame
    Up to 4 years and 2 months from start of treatment
  4. description
    Median number of months that patients remain alive after end of treatment.
    measure
    Overall Survival (OS)
    time Frame
    Up to 4 years and 2 months from start of treatment
Full study description
brief Summary
This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.
detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerable dose (MTD) and recommended phase II dose (RP2D) of oral triapine when used in combination with cisplatin plus radiation therapy. II. To determine the oral bioavailability of triapine. III. To describe the pharmacokinetics (PK) of oral and intravenous triapine. SECONDARY OBJECTIVES: I. To determine whether the metabolic complete response (mCR) rate of oral triapine in combination with cisplatin chemoradiation using fludeoxyglucose F 18 (18F-FDG)-positron emission tomography (PET)/computed tomography (CT) at post-therapy (3-month) is at least 70%. II. To determine clinical overall response rate, progression-free survival, and overall survival. III. To determine the correlation of methemoglobin proportion (%) and triapine pharmacokinetic exposure. EXPLORATORY OBJECTIVE: I. To determine whether active human immunodeficiency virus (HIV) antiretroviral therapy impacts the antitumor activity of triapine. OUTLINE: This is a dose-escalation study of triapine. Patients undergo pelvic external beam radiation therapy (EBRT) or intensity modulated radiation therapy (IMRT) 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of low dose rate (LDR) brachytherapy in week 6 or 5 fractions of high dose rate (HDR) brachytherapy at week 4 or 5. Patients also receive triapine intravenously (IV) over 120 minutes on day 1 and orally (PO) on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo magnetic resonance imaging (MRI) and FDG-PET/CT during follow-up.
Source references
references
  1. citation
    Taylor SE, Behr S, Cooper KL, Mahdi H, Fabian D, Gallion H, Ueland F, Vargo J, Orr B, Girda E, Courtney-Brooks M, Olawaiye AB, Randall LM, Richardson DL, Sullivan SA, Huang M, Christner SM, Beriwal S, Lin Y, Chauhan A, Chu E, Kohn EC, Kunos C, Ivy SP, Beumer JH. Dose finding, bioavailability, and PK-PD of oral triapine with concurrent chemoradiation for locally advanced cervical cancer and vaginal cancer (ETCTN 9892). Cancer Chemother Pharmacol. 2024 Dec 14;95(1):4. doi: 10.1007/s00280-024-04720-1.
    pmid
    39673591
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice