The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
197
Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).
260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy
Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7).
Time frame: Month 7
Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy
Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10).
Time frame: Month 10
The Cumulative Dose of Taxane Delivered During Study
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10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).
6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.
Sedona, Arizona, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Torrington, Connecticut, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Columbia, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Henderson, Nevada, United States
Unnamed facility
Raleigh, North Carolina, United States
...and 17 more locations
The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).
Time frame: approximately week 9-16
Mean Taxane Dose Intensity Per Week
Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.
Time frame: approximately week 9-16
Percent of Protocol Taxane Dose
Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.
Time frame: approximately week 9-16
Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays
Counts of participants who * completed the protocol-defined treatment cycles, * had a dose interruption * had a dose reduction * had a dose delay. A dose delay refers to the delay of all interventions in the cycle. Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Use of pegfilgrastim is included in the summary.
Time frame: up to Week 46
Myelosuppression During Taxane Dosing Cycles
Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE). * Grade 1 = \<lower limit of normal (LLN)-1.5\*10\^9/L * Grade 2 = \<1.5 - 1.0\*10\^9/L * Grade 3 = \<1.0 - 0.5\*10\^9/L * Grade 4 = \<0.5\*10\^9/L Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators.
Time frame: Weeks 9-16
Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation
Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.
Time frame: up to week 46
Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)
Summary of the most severe grades using the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests. Grade 0 = within normal range for all measurements. Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST): * Grade 1 = \> upper limit of normal (ULN) - 2.5\*ULN * Grade 2= \>2.5-5.0\*ULN * Grade 3= \>5.0-20.0\*ULN * Grade 4= \>20.0\*ULN Bilirubin: * Grade 1= \>ULN - 1.5\*ULN * Grade 3= \>3.0 - 10.0\*ULN Creatinine: \- Grade 1= \>ULN - 1.5\*ULN
Time frame: Week 1 up to week 50