Trial Outcomes & Findings for Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy (NCT NCT00691054)

NCT ID: NCT00691054

Last Updated: 2017-05-11

Results Overview

Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-05-11

Participant Flow

Participant milestones

Measure	Abraxane One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Abraxane One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy

Baseline characteristics by cohort

Measure	Abraxane n=20 Participants Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Stage-IV Disease	18 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Overall Survival Rate at 6 Months	58 percentage of participants Interval 33.0 to 76.0

SECONDARY outcome

Timeframe: 6 months

Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Number of Participants Showing Complete or Partial Response	1 participants

SECONDARY outcome

Timeframe: 12 months

Number of participants showing stable disease according to RECIST 1.0 criteria

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Number of Participants Showing Stable Disease	6 participants

SECONDARY outcome

Timeframe: 6 months

Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Progression-free Survival	1.7 months Interval 1.5 to 3.5

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Number of Participants Experiencing Adverse Events	19 Participants

SECONDARY outcome

Timeframe: 12 months

Median overall survival rate of participants measured in months

Outcome measures

Measure	Abraxane n=19 Participants One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Median Overall Survival of Participants	7.3 months Interval 2.8 to 15.8

Adverse Events

Abraxane

Serious events: 10 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abraxane n=19 participants at risk Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Infections and infestations Grade 3-4 Neutropenia	31.6% 6/19
Infections and infestations Grade 3-4 Neutropenic Fever	10.5% 2/19
Blood and lymphatic system disorders Grade 3-4 Anemia	10.5% 2/19

Other adverse events

Measure	Abraxane n=19 participants at risk Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Gastrointestinal disorders Grade 1-2 Nausea	63.2% 12/19
Metabolism and nutrition disorders Grade 1-2 Anorexia	47.4% 9/19
Metabolism and nutrition disorders Grade 1-2 Hypocalcemia	36.8% 7/19
Gastrointestinal disorders Grade 1-2 Vomiting	26.3% 5/19

Additional Information

Caio Max Rocha Lima MD

University of Miami Sylvester Comprehensive Cancer Center

Phone: 305-243-7770

Email: crocha@med.miami.edu

Results disclosure agreements

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