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NCT00046917 · ClinicalTrials.gov registry record · Phase 1

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT00046917: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00046917 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00046917, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Primary Outcome

Defined as the dose one level below the dose at which two or more of the patients in the initial cohort experience dose limiting toxicity (DLT) during the first treatment course. DLT is defined as the occurrence of Grade 4 hematologic toxicity, Grade 3 or 4 non-hematologic toxicity including diarrhea despite antidiarrheal prophylaxis, or any delay in treatment resulting in less than 2 treatments in 3 weeks.

Interventions

  • DRUG cisplatin
  • DRUG irinotecan hydrochloride
  • DRUG alvocidib

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2002-07
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00046917 record still lists

NCT00046917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.

NCT00046917 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00046917 about?

NCT00046917 is a clinical study titled "Combination Chemotherapy in Treating Patients With Advanced Solid Tumors". Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may ...

What is the current status of trial NCT00046917?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2002-07.

What interventions are being tested in trial NCT00046917?

The interventions under investigation include: cisplatin (DRUG), irinotecan hydrochloride (DRUG), alvocidib (DRUG).

Who is sponsoring clinical trial NCT00046917?

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 NCT00046917's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 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 NCT00046917, the US trial registry maintained by the National Library of Medicine. NCT00046917 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.