Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies
Public ClinicalTrials.gov record NCT00335998. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Study of Intravenous Triapine® (IND #68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP and cisplatin may make tumor cells more sensitive to radiation therapy. Giving 3-AP and external-beam radiation therapy together with cisplatin may kill more tumor cells. This phase I trial is studying the side effects and best dose of 3-AP when given together with external-beam radiation therapy with or without cisplatin in treating patients with gynecologic cancer
Study identification
- NCT ID
- NCT00335998
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
- Recurrent Cervical Cancer
- Recurrent Ovarian Epithelial Cancer
- Recurrent Vaginal Cancer
- Recurrent Vulvar Cancer
- Stage III Vaginal Cancer
- Stage IIIA Cervical Cancer
- Stage IIIA Ovarian Epithelial Cancer
- Stage IIIA Vulvar Cancer
- Stage IIIB Cervical Cancer
- Stage IIIB Ovarian Epithelial Cancer
- Stage IIIB Vulvar Cancer
- Stage IIIC Ovarian Epithelial Cancer
- Stage IIIC Vulvar Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IVA Cervical Cancer
- Stage IVA Vaginal Cancer
- Stage IVB Cervical Cancer
- Stage IVB Vaginal Cancer
Interventions
- triapine Drug
- laboratory biomarker analysis Other
- external beam radiation therapy Radiation
- brachytherapy Radiation
- cisplatin Drug
- pharmacological study Other
Drug · Other · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2006
- Primary completion
- Sep 30, 2008
- Completion
- Not listed
- Last update posted
- Jan 10, 2013
Started 2006
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00335998, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2013 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00335998 live on ClinicalTrials.gov.