Triapine + Chemotherapy/Radiation for Cervical and Vaginal Cancers

Recruiting at409 trial locations

Overseen by Charles A Leath

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Research Team

Charles A Leath

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

Absolute neutrophil count > 1,500/uL

Platelets > 100,000/uL

Exclusion Criteria

I have been diagnosed with G6PD deficiency.

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

Patient is receiving another investigational agent for the treatment of cancer

Treatment Details

Interventions

• Cisplatin (Alkylating agents)
• Triapine (Anti-cancer Drug)

Trial Overview 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.

Participant Groups

Group I: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine) Experimental Treatment 6 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 Control 6 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.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School