Experimental drug combo shows promise for Tough-to-Treat gynecologic cancers
NCT ID NCT02595879
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-phase study tested an oral drug called triapine added to standard chemotherapy (cisplatin) and radiation for people with advanced cervical or vaginal cancer. The main goals were to find the safest dose and check how well the body absorbs the drug. Twenty-one participants were enrolled, and researchers monitored side effects and tumor response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Sep 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
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Los Angeles General Medical Center
Los Angeles, California, 90033, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
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University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
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University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
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University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.