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Clinical Trial Summary

This phase II trial is studying how triapine and cisplatin given together with radiation therapy works in treating patients with cervical cancer or vaginal cancer. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triapine together with cisplatin may make tumor cells more sensitive to radiation therapy.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine three-month fasting F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET/CT) imaging complete metabolic response as defined by the European Organization for Research and Treatment of Cancer (EORTC) PET study group.

SECONDARY OBJECTIVES:

I. To determine 6-month progression-free survival rate as calculated from the date of first treatment until date of disease progression, relapse, or death.

II. To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and post-treatment PET/CT or disease progression PET/CT.

III. To quantitate pre-treatment, during treatment and 3-mo post-treatment grade 2 or higher gastrointestinal, genitourinary, and sexual function toxicity resulting from Triapine®, cisplatin, and radiation therapy as measured by CTCAE v3.0, which will be utilized until December 31, 2010; CTCAE v4.0 will be utilized beginning January 1, 2011.

IV. To associate smoking habit (non-smoker, smoker who quit during therapy, smoker) with 3-mo post-treatment PET/CT metabolic response and 3-mo best overall clinical response as measured by RECIST criteria after Triapine®, cisplatin, and radiation therapy.

V. To associate HPV or non-HPV sub-type cervical cancer with 3-mo post-treatment PET/CT metabolic response and 3-mo best overall clinical response as measured by RECIST criteria after Triapine®, cisplatin, and radiation therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to brachytherapy treatment (planned intracavitary brachytherapy vs none).

Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.

Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression.

After completion of study treatment, patients are followed periodically for up to 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00941070
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date July 2012

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