Triapine + Chemoradiation for Cervical or Vaginal Cancer

Palo Alto (17 mi)

Overseen bySarah E Taylor

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with stage IB2-IVA cervical or vaginal cancer who can take oral meds, have a life expectancy over 6 months, and proper liver/kidney function. They must not be pregnant/breastfeeding and agree to use contraception. Excluded are those with recent cancers (except certain skin/cervical cancers), prior pelvic radiation, G6PD deficiency, uncontrolled diabetes or other serious illnesses.

Inclusion Criteria

I have a new diagnosis of advanced cervical or vaginal cancer and can undergo a PET/CT scan.

I am 18 years old or older.

I can take care of myself and am up and about more than half of my waking hours.

My kidney function is sufficient for cisplatin, with creatinine between 1.5-1.9 mg/dL and clearance over 30 ml/min.

My hepatitis B virus load is undetectable with treatment.

My kidney function is good enough for certain chemotherapy.

I had hepatitis C but am cured, or if currently treated, my viral load is undetectable.

Exclusion Criteria

My diabetes is under control with medication, and my fasting blood sugar is <= 200 mg/dL.

I have not had, nor am I planning to have, a hysterectomy as part of my cervical cancer treatment.

I have not had cancer, except for non-melanoma skin cancer or cervical carcinoma in situ, in the last 3 years.

I have stopped taking any medication that can cause methemoglobinemia for the required time.

I am allergic to medications similar to triapine or cisplatin.

I do not have any severe illnesses that could interfere with the study.

Treatment Details

The trial tests the safety and optimal dose of Triapine combined with cisplatin chemotherapy and radiation therapy in treating cervical/vaginal cancer. It explores whether adding Triapine enhances the effectiveness of standard treatments by inhibiting an enzyme needed for cancer cell growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (triapine, chemoradiation)Experimental Treatment12 Interventions

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: