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Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

NCT00256282 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-05-03

Study results available
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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.

Conditions

Interventions

DRUG

Vinorelbine

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

DRUG

Docetaxel

40mg/m2 IV over 1 hour every 14 days

DRUG

Sargramostim

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • John P. Fruehauf

    lead OTHER

Principal Investigators

  • John P. Fruehauf, MD, PhD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256282 on ClinicalTrials.gov