Trial Outcomes & Findings for Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma (NCT NCT00256282)

NCT ID: NCT00256282

Last Updated: 2018-05-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Six months from initial treatment
• Results posted on: 2018-05-03

Participant Flow

Participant milestones

Measure	Docetaxel and Vinorelbine Plus Sargramostim Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
Overall Study STARTED	52
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Docetaxel and Vinorelbine Plus Sargramostim Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
Overall Study Disease progression, relapse during acti	12
Overall Study Adverse Event	3
Overall Study Physician Decision	1

Baseline Characteristics

Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

Baseline characteristics by cohort

Measure	Docetaxel and Vinorelbine Plus Sargramostim n=52 Participants The DVS regimen consisted of docetaxel 40 mg/m2 IV over 1 hour, vinorelbine 30 mg/m2 IV over 6 to 10 minutes on day 1, every 14 days, and GM-CSF, 250 mg/m2 SC on days 2 to 12. Patients received a cycle of this regimen every two weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	62.0 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Docetaxel and Vinorelbine Plus Sargramostim n=52 Participants Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
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	134 days Interval 91.0 to 214.0

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Docetaxel and Vinorelbine Plus Sargramostim n=52 Participants Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
Percentage of Patients Alive at One Year	25 Participants

Adverse Events

Docetaxel and Vinorelbine Plus Sargramostim

Serious events: 6 serious events

Other events: 42 other events

Deaths: 15 deaths

Serious adverse events

Measure	Docetaxel and Vinorelbine Plus Sargramostim n=52 participants at risk Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
General disorders febrile neutropenia	11.5% 6/52 • Number of events 6 • 6 years, 6 months

Other adverse events

Measure	Docetaxel and Vinorelbine Plus Sargramostim n=52 participants at risk Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ) Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days Docetaxel: 40mg/m2 IV over 1 hour every 14 days Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
Blood and lymphatic system disorders anemia	80.8% 42/52 • Number of events 42 • 6 years, 6 months
Blood and lymphatic system disorders neutropenia	36.5% 19/52 • Number of events 19 • 6 years, 6 months
Blood and lymphatic system disorders thrombocytopenia	17.3% 9/52 • Number of events 9 • 6 years, 6 months
Nervous system disorders neuropathy	30.8% 16/52 • Number of events 16 • 6 years, 6 months
General disorders alopecia	76.9% 40/52 • Number of events 50 • 6 years, 6 months
General disorders Injection site reaction	25.0% 13/52 • Number of events 13 • 6 years, 6 months

Additional Information

Dr. John P. Fruehauf

University of California, Irvine

Phone: 714-456-5153

Email: jfruehau@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place