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NCT00404235 · ClinicalTrials.gov registry record · Phase 2

Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

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

Completed
Registry status
Phase 2
Development phase
76
Enrollment target

NCT00404235: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00404235 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00404235, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
76 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.

Primary Outcome

The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apar

Interventions

  • DRUG carboplatin
  • DRUG paclitaxel albumin-stabilized nanoparticle formulation

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2006-10
Est. Completion 2010-03
Phase Phase 2

What the finished NCT00404235 record still lists

NCT00404235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 2 interventions - of which carboplatin is the first listed.

NCT00404235 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00404235 about?

NCT00404235 is a clinical study titled "Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery". RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II tri...

What is the current status of trial NCT00404235?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2006-10. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00404235?

The interventions under investigation include: carboplatin (DRUG), paclitaxel albumin-stabilized nanoparticle formulation (DRUG).

Who is sponsoring clinical trial NCT00404235?

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 NCT00404235's enrollment target sits among peer trials

76 893rd of 2000 higher than 1,101 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 NCT00404235, the US trial registry maintained by the National Library of Medicine. NCT00404235 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.