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NCT00335998 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00335998: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00335998 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00335998, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

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

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG cisplatin
  • RADIATION brachytherapy
  • DRUG triapine
  • RADIATION external beam radiation therapy

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2006-03
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00335998 record still lists

NCT00335998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT00335998 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00335998 about?

NCT00335998 is a clinical study titled "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". 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...

What is the current status of trial NCT00335998?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-03.

What interventions are being tested in trial NCT00335998?

The interventions under investigation include: laboratory biomarker analysis (OTHER), cisplatin (DRUG), brachytherapy (RADIATION), triapine (DRUG), external beam radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00335998?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00335998's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00335998, the US trial registry maintained by the National Library of Medicine. NCT00335998 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.