Trial Outcomes & Findings for Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial (NCT NCT00041470)

NCT ID: NCT00041470

Last Updated: 2017-07-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-07-17

Participant Flow

Participant milestones

Measure	Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment. Paclitaxel is administered weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy. Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression
Overall Study STARTED	38
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Measure

Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment. Paclitaxel is administered weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy. Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression

Overall Study Loss of Funding

38

Baseline Characteristics

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

Baseline characteristics by cohort

Measure	Phase I/II n=38 Participants Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment. Paclitaxel is administered weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy. Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr
Age, Continuous	46.5 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Baseline Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Weekly Paclitaxel, Vinorelbine and GCSF n=38 Participants Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Paclitaxel weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Herceptin: 4 mg/kg IV loading dose day 1
To Measure Response Rates, Time to Progression and Survival in Patients so Treated. Complete Response	6 Participants
To Measure Response Rates, Time to Progression and Survival in Patients so Treated. Partial Response	14 Participants
To Measure Response Rates, Time to Progression and Survival in Patients so Treated. Stable Disease	9 Participants
To Measure Response Rates, Time to Progression and Survival in Patients so Treated. Progressive Disease	8 Participants
To Measure Response Rates, Time to Progression and Survival in Patients so Treated. Inevaluable	1 Participants

SECONDARY outcome

Timeframe: <=18 months

Outcome measures

Measure	Weekly Paclitaxel, Vinorelbine and GCSF n=38 Participants Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Paclitaxel weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Herceptin: 4 mg/kg IV loading dose day 1
To Measure the Qualitative and Quantitative Toxicity of This Regimen. >=Grade 3 Toxicity	30 Participants
To Measure the Qualitative and Quantitative Toxicity of This Regimen. serious adverse events	10 Participants

Adverse Events

Weekly Paclitaxel and Vinorelbine With GCSF Support

Serious events: 10 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Weekly Paclitaxel and Vinorelbine With GCSF Support n=38 participants at risk Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Paclitaxel administered weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy. Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	2.6% 1/38 • Number of events 1 • 1 year
Blood and lymphatic system disorders Leukopenia	10.5% 4/38 • Number of events 4 • 1 year
Infections and infestations Mucositis	5.3% 2/38 • Number of events 2 • 1 year
Cardiac disorders Congestive Heart Failure	2.6% 1/38 • Number of events 1 • 1 year
Infections and infestations Febrile Neutropenia	5.3% 2/38 • Number of events 2 • 1 year

Other adverse events

Measure	Weekly Paclitaxel and Vinorelbine With GCSF Support n=38 participants at risk Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. Paclitaxel administered weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy. Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr
Blood and lymphatic system disorders Neutropenia	52.6% 20/38 • Number of events 20 • 1 year
Blood and lymphatic system disorders Thrombocytopenia	42.1% 16/38 • Number of events 16 • 1 year
Gastrointestinal disorders Vomiting	10.5% 4/38 • Number of events 4 • 1 year

Additional Information

Julie Gralow, MD

University of Washington

Phone: 206-288-2053

Email: pink@u.washington.edu

Results disclosure agreements

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