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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from off-treatment date

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from off-treatment date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from off-treatment date

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicity (DLT) to determine maximum tolerated dose (MTD)

Oral bioavailability of the oral form of the triapine

Secondary outcome measures

Clinical overall response

Fludeoxyglucose F 18-Positron emission tomography computed tomography metabolic complete response (mCR) rate

Incidence of toxicity

+3 more

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

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

Brachytherapy

2007

Completed Phase 3

~2100

Triapine

2006

Completed Phase 1

~30

Cisplatin

2013

Completed Phase 3

~1940

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,131 Total Patients Enrolled

Sarah E TaylorPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO

1 Previous Clinical Trials

350 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02595879 — Phase 1

Cervical Cancer Research Study Groups: Treatment (triapine, chemoradiation)

Cervical Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02595879 — Phase 1

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595879 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies can External Beam Radiation Therapy be applied to alleviate?

"External Beam Radiation Therapy is often utilized to treat advanced ovarian cancer and can be used in a range of other scenarios, including cases where traditional treatments have proven ineffective, neoplasm metastases, and for end-of-life care."

Answered by AI

What aims is this research trying to accomplish?

"This trial, to be assessed between Days 1 and 11, aims at determining the Maximum Tolerated Dose by evaluating Incidence of dose-limiting toxicity (DLT). Secondary outcomes include a Fludeoxyglucose F 18 (18F-FDG)-Positron emission tomography (PET) computed tomography (CT) metabolic complete response rate with corresponding 95% confidence interval. Additionally, Overall Survival will be monitored using Kaplan Meier's Method whilst Standard Pharmacokinetics Parameters such as maximum concentration, time to maximum concentration et cetera are evaluated descriptively. Lastly, Spearman Correlation Coefficients shall measure association"

Answered by AI

How many healthcare facilities are actively conducting this experiment?

"Currently, 8 clinical trial sites have opened across the United States and are accepting patients. These locations include Lexington, Ann Arbor and Farmington Hills as well as 5 other cities. To ease travel demands for prospective participants, it is advisable to select a site closest to you."

Answered by AI

What is the current patient count of this medical experiment?

"Confirmed. Clinicaltrials.gov records indicate that this medical experiment, which was first distributed on May 27th 2016, is presently recruiting patients. 76 participants need to be enrolled from 8 different sites."

Answered by AI

How can External Beam Radiation Therapy be detrimental to a patient's health?

"In our assessment, External Beam Radiation Therapy's safety rating is at a 1 due to the limited efficacy and safety data available in this Phase 1 trial."

Answered by AI

Are there still openings available for individuals to join this trial?

"Correct. According to clinicaltrials.gov, this trial is currently seeking patients and has been since May 27th 2016 with the most recent modification being made on November 29th 2022. The research aims to recruit 76 participants from 8 medical sites."

Answered by AI

Could you please explain the outcomes of past studies involving External Beam Radiation Therapy?

"External Beam Radiation Therapy was first assessed in 1997 at the City of Hope Comprehensive Cancer Centre. Since then, 1667 completed trials have been conducted and 749 are currently recruiting participants, many of which take place in Lexington Kentucky."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

2019. "Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02595879.

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