Clinical trial NCT00691054: Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Official title: Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival Rate at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Showing Complete or Partial Response
timeFrame: 6 months
measure: Number of Participants Showing Stable Disease
timeFrame: 12 months
measure: Progression-free Survival
timeFrame: 6 months
measure: Number of Participants Experiencing Adverse Events
timeFrame: 6 months
measure: Median Overall Survival of Participants
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Centre
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Caio Max S. Rocha Lima, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins Singapore International Medical Centre
name: Gilberto Lopes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. doi: 10.1097/COC.0b013e3182436e8c.