Trial Outcomes & Findings for Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer (NCT NCT00615901)
NCT ID: NCT00615901
Last Updated: 2017-03-03
Results Overview
the study regimen is deemed feasible and tolerable for patients with ANC \> 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
2 years
Results posted on
2017-03-03
Participant Flow
Participant milestones
| Measure |
Cohort A (CMF at 14 Day Intervals)
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Cohort A (CMF at 14 Day Intervals)
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
7
|
Baseline Characteristics
Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (CMF at 14 Day Intervals)
n=38 Participants
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
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|---|---|
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Age, Continuous
|
52 years
n=99 Participants
|
|
Gender
Female
|
38 Participants
n=99 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsthe study regimen is deemed feasible and tolerable for patients with ANC \> 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.
Outcome measures
| Measure |
Cohort A (CMF at 14 Day Intervals)
n=29 Participants
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
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|---|---|
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The Number of Patients Who Completed 8 Cycles.
|
29 participants
|
Adverse Events
Cohort A (CMF at 14 Day Intervals)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (CMF at 14 Day Intervals)
n=38 participants at risk
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Number of events 1
|
|
Nervous system disorders
Seizure
|
2.6%
1/38 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/38
|
|
Infections and infestations
Skin infection
|
0.00%
0/38
|
Other adverse events
| Measure |
Cohort A (CMF at 14 Day Intervals)
n=38 participants at risk
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.
cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Fatigue
|
7.9%
3/38 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
4/38 • Number of events 4
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
4/38 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
2/38 • Number of events 3
|
Additional Information
Dr. Pamela Drullinksy
Memorial Sloan Kettering Cancer Center
Phone: 516-256-3955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place