Triapine + Chemoradiation for Cervical or Vaginal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and assess the side effects of a new treatment combination for cervical or vaginal cancer. It combines triapine, an experimental treatment that may inhibit cancer cell growth, with standard treatments such as radiation and cisplatin, a chemotherapy drug. Participants should have a new diagnosis of certain stages of cervical or vaginal cancer that cannot be surgically removed. This trial may suit those who can undergo imaging tests and take oral medication and have not received certain prior treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.
Do I need to stop taking my current medications for the trial?
The trial requires that you stop taking any medications associated with methemoglobinemia, with a washout period (time without taking the medication) of 4 half-lives or 4 weeks, whichever is shorter. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using triapine with cisplatin and radiation therapy safely treats certain cancers. In past studies, patients with advanced cervical cancer tolerated this combination well. Most side effects were manageable and similar to those from other cancer treatments, with common side effects including low blood cell counts and nausea.
Cisplatin, a well-known chemotherapy drug, is generally safe and often used in cancer treatments. Its side effects can include kidney problems and nerve damage, but these are closely monitored during treatment. Overall, earlier studies demonstrated that the combination of triapine, cisplatin, and radiation is safe, though monitoring side effects remains important.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Triapine in combination with chemoradiation for cervical or vaginal cancer because it introduces a new way to enhance the effectiveness of traditional treatments. Unlike standard therapies that mainly rely on radiation and chemotherapy alone, Triapine targets a specific enzyme involved in cancer cell metabolism, potentially making cancer cells more sensitive to radiation. This unique mechanism may improve the overall effectiveness of treatments like cisplatin and external beam radiation therapy. By combining Triapine with these existing treatments, there's hope for better outcomes and fewer side effects, making it a promising option for patients.
What evidence suggests that this trial's treatments could be effective for cervical or vaginal cancer?
Research has shown that adding triapine to the usual treatment for cervical and vaginal cancer appears promising. Triapine stops an enzyme that cancer cells need to grow. In this trial, participants will receive a combination of triapine, cisplatin, and radiation. Studies have found that using triapine with cisplatin (a chemotherapy drug that damages cancer cell DNA) and radiation has led to high success rates in patients. Specifically, one study found that 83% of patients were still alive 30 months after treatment with triapine, cisplatin, and radiation. Cisplatin alone is already a common treatment for cervical cancer, and using more than 200 mg has been linked to better survival rates. Together, these treatments offer a hopeful way to fight these cancers.36789
Who Is on the Research Team?
Sarah E Taylor
Principal Investigator
University of Pittsburgh Cancer Institute LAO
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive triapine in combination with cisplatin and radiation therapy for cervical or vaginal cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI and FDG-PET/CT scans
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Brachytherapy
- Cisplatin
- External Beam Radiation Therapy
- High-Dose Rate Brachytherapy
- Intensity-Modulated Radiation Therapy
- Triapine
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Efficacy of cumulative cisplatin dose on survival in patients ...
Our study showed that a cumulative cisplatin dose >200 mg, particularly in patients with lymph node metastases, significantly improved ...
The efficacy of cumulative cisplatin dose on survival in ...
Results: The median cumulative cisplatin dose was 210 mg (range, 40-320 mg), and it was ≥200 mg in 503 (76.9%) patients. Median follow-up was 35 ...
SGO, FWC, and GOG-F* Communique
For the treatment of cervical cancer, cisplatin or carboplatin is recommended in evidence-based guidelines as the first-line standard of care, ...
Efficacy of cumulative cisplatin dose on survival in patients ...
Our study indicated that a cumulative cisplatin dose of ≥200mg improved overall survival in patients with FIGO stage III cervical cancer. Advanced age, poorer ...
Localized Delivery of Cisplatin to Cervical Cancer ...
In this study, we aimed to develop an intra-cervical drug delivery system that allows cisplatin release directly into the tumor and minimize systemic side ...
Cisplatin-Containing Combinations Associate with Survival in ...
For a first-line cisplatin-containing regimen, the median progression-free survival was 6.5 months (95% confidence interval: 5.5–7.7 months).
Cisplatin-Based Chemotherapy of Human Cancers - PMC
Cisplatin is a potent chemotherapeutic drug that has shown efficacy for the treatment of many malignancies including head and neck, ovarian, sarcomas, lymphoma ...
Treatment Compliance and Outcomes for Women With ...
This study aims to assess treatment compliance among women undergoing definitive chemoradiation with weekly cisplatin for cervical cancer within a safety ...
Phase III study of cisplatin with or without S-1 in patients ...
The S-1 plus cisplatin regimen demonstrated a tolerable safety profile in patients with stage IVB, recurrent, or persistent cervical cancer.
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