Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
Detailed description
OBJECTIVES: Primary * To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen. Secondary * To determine the safety and characterize the toxicity profile of this drug. * To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease. * To determine CA 19-9 response. * To determine progression-free survival. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.
Interventions
DRUGAbraxane
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
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen. 2. Patients have to be 18 years-old or older 3. Able to give signed Informed consent 4. Adequate end-organ function with laboratory parameters as follows: * Neutrophils: 1.5 x10\^9/L or greater * Plts: 100 x10\^9/L or greater * Hemoglobin: ≥ 9.0g/dL * Serum Creatinine: ≤ 1.5mg/dL * Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN) * Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN 5. Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study 6. Measurable or non-measurable disease by RECIST criteria 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 8. Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity 9. Life expectancy greater than 3 months 10. Willing and able to comply with the protocol requirement. 11. Patients must not have any peripheral neuropathy equal or greater than grade 2
Exclusion criteria
1. Chemotherapy within 3 weeks prior to enrollment 2. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment. 3. Any major surgery within 4 weeks prior to enrollment 4. Peripheral neuropathy equal to or greater than grade 2 5. Clinical AIDS or known positive HIV serology 6. Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years 7. Unstable angina 8. New York Heart Association (NYHA) Grade II or greater congestive heart failure 9. History of myocardial infarction within 3 months 10. History of stroke within 3 months 11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study 12. Pregnant (positive pregnancy test) or lactating 13. Inability to comply with study and/or follow-up procedures 14. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible. 15. Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Showing Complete or Partial Response | 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. |
| Number of Participants Showing Stable Disease | 12 months | Number of participants showing stable disease according to RECIST 1.0 criteria |
| Progression-free Survival | 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. |
| Number of Participants Experiencing Adverse Events | 6 months | — |
| Median Overall Survival of Participants | 12 months | Median overall survival rate of participants measured in months |
Countries
Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abraxane 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Abraxane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 61 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
| Stage-IV Disease | 18 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 19 |
| serious Total, serious adverse events | 10 / 19 |
Outcome results
Primary
Overall Survival Rate at 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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abraxane | Overall Survival Rate at 6 Months | 58 percentage of participants |
Secondary
Median Overall Survival of Participants
Median overall survival rate of participants measured in months
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abraxane | Median Overall Survival of Participants | 7.3 months |
Secondary
Number of Participants Experiencing Adverse Events
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abraxane | Number of Participants Experiencing Adverse Events | 19 Participants |
Secondary
Number of Participants Showing Complete or Partial Response
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abraxane | Number of Participants Showing Complete or Partial Response | 1 participants |
Secondary
Number of Participants Showing Stable Disease
Number of participants showing stable disease according to RECIST 1.0 criteria
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abraxane | Number of Participants Showing Stable Disease | 6 participants |
Secondary
Progression-free Survival
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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abraxane | Progression-free Survival | 1.7 months |