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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. 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

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00335998

The ClinicalTrials.gov registry entry for NCT00335998 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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

NCT00335998 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.