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Alkylating agents

Triapine + Chemoradiation for Cervical or Vaginal Cancer

Phase 1

Waitlist Available

Led By Sarah E Taylor

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years and 2 months from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of triapine when given with standard radiation and cisplatin treatment for patients with cervical or vaginal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to blocking enzymes necessary for cell growth which may affect normal cells as well as cancer cells, typical chemotherapy-related issues like nausea and hair loss, plus risks associated with radiation such as fatigue and skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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

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

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My hepatitis B virus load is undetectable with treatment.

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My kidney function is good enough for certain chemotherapy.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I am allergic to medications similar to triapine or cisplatin.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 2 months from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 2 months from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 2 months from start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC

Bioavailability of Triapine

Cmax

+3 more

Secondary study objectives

Clinical Overall Response Rate

Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Biospecimen Collection

2004

Completed Phase 3

~2030