Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the… (NCT04494113) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Testing the Response to the Anti-cancer Drug, Triapine, in Uterine Cancers Using Markers From the Tissue at the Time of Hysterectomy
United States12 participantsStarted 2022-02-08
Plain-language summary
This early phase I trial investigates the response to the anti-cancer drug, triapine, in uterine cancers by using markers from tissue samples at the time of removal of the uterus, ovaries, and fallopian tubes (hysterectomy and bilateral salpingo-oophorectomy). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding triapine to the usual approach of surgery followed by chemotherapy alone or in combination with radiation therapy may help to slow the growth of uterine cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients must have histologically confirmed uterine corpus serous adenocarcinoma
* Patients must be planned for surgical hysterectomy and operative staging
* Patients must have adequate archival tissue obtained within 8 weeks of step 1 registration OR have sufficient tumor tissue and be willing to undergo an endometrial pipelle biopsy prior to beginning study treatment.
* Patients must have adequate primary tumor volume, as determined by imaging (e.g., computed tomography \[CT\], ultrasound, magnetic resonance imaging \[MRI\]) at eligibility screening, to accommodate research specimen collections in addition to clinical pathology evaluation
* Patients must not have received any prior anticancer treatment for endometrial cancer
* Patients must be \>= 18 years old. Because no dosing or adverse event data are currently available on the use of triapine in patients \< 18 years of age, children are excluded from this study
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count \>= 1,000/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 9.0 g/dL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
* International normalized ratio (INR) =\< 2
* Creatinine =\< 1.5 x instituti…