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NCT00680758 · ClinicalTrials.gov registry record · Phase 1

Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer

A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00680758: Completed Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

NCT00680758 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00680758, a Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.

Primary Outcome

The Maximum Tolerated Dose (MTD) will be the dose level at which fewer than 2 of 6 (or 33% of) patients experience dose limiting toxicity (DLT).

Interventions

  • DRUG cisplatin
  • DRUG paclitaxel
  • DRUG everolimus

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2008-05
Est. Completion 2010-12
Phase Phase 1
Vanderbilt-Ingram Cancer Center

189 total trials

What the finished NCT00680758 record still lists

NCT00680758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

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

NCT00680758 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00680758 about?

NCT00680758 is a clinical study titled "Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Givi...

What is the current status of trial NCT00680758?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-05. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00680758?

The interventions under investigation include: cisplatin (DRUG), paclitaxel (DRUG), everolimus (DRUG).

Who is sponsoring clinical trial NCT00680758?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00680758's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT00680758, the US trial registry maintained by the National Library of Medicine. NCT00680758 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.