CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Vinorelbine +2 moredrug
Likely dose
Vinorelbine 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00256282
NCT00256282Phase 2Completed

A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma

John P. Fruehauf·interventional·Posted Nov 21, 2005·Updated May 3, 2018

In Brief

A Phase 2 clinical trial evaluating Vinorelbine, Docetaxel, and 1 other intervention for Metastatic Melanoma. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2005
Enrollment StartApr 1, 2003
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.6 years ago

Interventions

Vinorelbinedrug

30 mg/m2 IV over 6-10 min every 14 days

Docetaxeldrug

40mg/m2 IV over 1 hour every 14 days

Sargramostimdrug

250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days