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Alkylating agents

Triapine + Chemotherapy/Radiation for Cervical and Vaginal Cancers

Phase 3

Waitlist Available

Led By Charles A Leath

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 must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent

Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) 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; NOTE: 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

Must not have

Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017)

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; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying radiation therapy and cisplatin with or without triapine in treating patients with newly diagnosed cervical or vaginal cancer.

Who is the study for?

This trial is for patients with advanced-stage cervical or vaginal cancer, specifically stages IB2, II, or IIIB-IVA. Participants must have adequate organ function (e.g., hemoglobin >10 g/dL, creatinine ≤1.5 mg/dL), no severe allergies to triapine, not be breastfeeding, and cannot have HIV or other conditions that would interfere with the study drugs.

What is being tested?

The trial is testing if adding Triapine to standard chemotherapy (Cisplatin) and radiation therapy improves outcomes in treating advanced cervical and vaginal cancers. It's a phase III study where some patients will receive the usual treatment while others will get the new combination including Triapine.

What are the potential side effects?

Possible side effects include typical chemotherapy-related issues like fatigue, nausea, kidney problems from Cisplatin; plus potential risks from Triapine such as low blood counts and allergic reactions. Radiation may cause skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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I have a certain type of cervical or vaginal cancer that cannot be cured by surgery alone.

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My creatinine level is 1.5 mg/dL or lower.

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My kidney function is within the range to receive cisplatin.

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My blood sugar levels are under control.

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I do not have brain metastases.

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I do not have HIV or am not on HIV treatment.

Exclusion Criteria

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

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I have been diagnosed with G6PD deficiency.

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I do not have any major health issues that are not under control.

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I have another active cancer besides the one being treated.

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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 am set to receive additional cancer treatment after my standard chemoradiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS) Rate at 3 Years

Secondary study objectives

Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period

Progression-free Survival (PFS) Rate at 3 Years

Other study objectives

Intensity Modulated Radiation Therapy (IG-IMRT)

Metabolic Complete Response (mCR)

Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)Experimental Treatment6 Interventions

Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (cisplatin, IMRT or RT, brachytherapy)Active Control6 Interventions

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brachytherapy

2007

Completed Phase 3

~2140

Cisplatin

2013

Completed Phase 3

~3120