A Study of Combination Radiation Therapy and Cisplatin with or without Triapine for Treating Patients with Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer

Overview

About this study

The purpose of this study is to see how well radiation therapy and cisplatin with triapine work in combination compared to the standard radiation therapy and cisplatin alone to treat 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Patient has a new, unrated histologic diagnosis of stage IB2 (> 5 cm), II, IIIB 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 para‐aortic lymph node metastasis will be based on pre-therapy 18F‐FDG PET/CT; 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.
  • Patient must have adequate organ and marrow function as defined below:
    • absolute neutrophil count > 1,500/μL
    • platelets > 100,000/μL
    • hemoglobin > 10 g/dL
    • total bilirubin < 2.0 mg/dL
    • AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
    • PT/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 there is no hydronephrosis and 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:
      • CCr = 0.85 x (140-age) x IBW / (Scr x72) where age is the patient’s age in years (from 20 to 80 years), Scr is the serum creatinine in mg/dL, and IBW is the ideal body weight in kg (according to the calculation IBW = 45.5 kg + 2.3 kg for each inch over 5 feet).
  • 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.
  • Age is ≥ 18 years.
  • 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; 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 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.
  • Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation.
  • Patients with self-reported or known diagnosis of G6PD deficiency.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Gretchen Glaser, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Gretchen Glaser, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20207995

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