Trial · NCT00256282
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
NCT00256282, Phase 2, Completed, John P. Fruehauf; results first posted 2018-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma. Trials, record NCT00256282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00256282
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
- NCT number
- NCT00256282
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- John P. Fruehauf
- Conditions
- Metastatic Melanoma
- Interventions
- Vinorelbine, Docetaxel, Sargramostim
- First posted
- 2005-11-21
- Last updated
- 2018-05-03
- Results first posted
- 2018-05-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy | Six months from initial treatment | The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan. |
| Secondary | Percentage of Patients Alive at One Year | 1 year |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy | Six months from initial treatment | days | MEDIAN | |
| SECONDARY | Percentage of Patients Alive at One Year | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy | Docetaxel and Vinorelbine Plus Sargramostim | 134 | 95% Confidence Interval 91 to 214 | days | |
| Percentage of Patients Alive at One Year | Docetaxel and Vinorelbine Plus Sargramostim | 25 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docetaxel and Vinorelbine Plus Sargramostim | 52 | |
| Overall Study | COMPLETED | Docetaxel and Vinorelbine Plus Sargramostim | 36 | |
| Overall Study | NOT COMPLETED | Docetaxel and Vinorelbine Plus Sargramostim | 16 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | anemia | Blood and lymphatic system disorders | Docetaxel and Vinorelbine Plus Sargramostim | 42 | 52 | 42 |
| other | neutropenia | Blood and lymphatic system disorders | Docetaxel and Vinorelbine Plus Sargramostim | 19 | 52 | 19 |
| other | thrombocytopenia | Blood and lymphatic system disorders | Docetaxel and Vinorelbine Plus Sargramostim | 9 | 52 | 9 |
| other | neuropathy | Nervous system disorders | Docetaxel and Vinorelbine Plus Sargramostim | 16 | 52 | 16 |
| other | alopecia | General disorders | Docetaxel and Vinorelbine Plus Sargramostim | 40 | 52 | 50 |
| other | Injection site reaction | General disorders | Docetaxel and Vinorelbine Plus Sargramostim | 13 | 52 | 13 |
| serious | febrile neutropenia | General disorders | Docetaxel and Vinorelbine Plus Sargramostim | 6 | 52 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel and Vinorelbine Plus Sargramostim | 15 | 52 |
| Total, other adverse events | Docetaxel and Vinorelbine Plus Sargramostim | 42 | 52 |
| Total, serious adverse events | Docetaxel and Vinorelbine Plus Sargramostim | 6 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21769667 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00256282
GET https://conductscience.org/api/trials/v1/NCT00256282/registered