A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2 Stage II IIIB or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Overview

This randomized phase II 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.

Description

The purpose of this study is to evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix cancer.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: cervical cancer,uterine cervix cancer,vaginal cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria
Patient has pathologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix not amenable to curative surgical resection alone
Patient does not have uncontrolled diabetes mellitus
Patient does not have known brain metastases
Patient does not have known human immunodeficiency virus syndrome
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
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 five years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix)
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; proteinuria 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 must agree to use two forms of birth control if they are of child-bearing potential


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX6613

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