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NCT00976573 · ClinicalTrials.gov registry record · Phase 2

Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma

A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
149
Enrollment target

NCT00976573: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00976573 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00976573, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
149 participants
Enrollment target

Study Summary

This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab work when given with or without everolimus in treating patients with malignant melanoma that has spread from where it started to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy given together with bevacizumab is more effective with or without everolimus in treating patients with metastatic melanoma.

Primary Outcome

The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smalle

Interventions

  • DRUG carboplatin
  • DRUG paclitaxel
  • DRUG everolimus
  • BIOLOGICAL bevacizumab

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2010-04
Est. Completion 2015-09
Phase Phase 2

What the finished NCT00976573 record still lists

NCT00976573 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher).

The record links to 0 conditions, and to 4 interventions - of which carboplatin is the first listed.

NCT00976573 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00976573 about?

NCT00976573 is a clinical study titled "Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma". This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab work when given with or without everolimus in treating patients with malignant melanoma that has spread from where it started to other places in the body. Drugs used in chemotherapy, such as carboplatin and ...

What is the current status of trial NCT00976573?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2010-04. Estimated completion is 2015-09.

What interventions are being tested in trial NCT00976573?

The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), everolimus (DRUG), bevacizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00976573?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00976573's enrollment target sits among peer trials

149 491st of 2000 higher than 1,510 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00976573, the US trial registry maintained by the National Library of Medicine. NCT00976573 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.