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

Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Abraxane

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Johns Hopkins Singapore International Medical Centre
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Number of Participants Showing Stable Disease	Number of participants showing stable disease according to RECIST 1.0 criteria	12 months
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.	6 months
Number of Participants Experiencing Adverse Events		6 months
Median Overall Survival of Participants	Median overall survival rate of participants measured in months	12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Gilberto Lopes, MD, Johns Hopkins Singapore International Medical Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 4, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (Estimate): June 5, 2008

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: recurrent pancreatic cancer; stage IV pancreatic cancer; stage III pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 20080055; SCCC-2007096 (Other Identifier: UMiami Sylvester Comprehensive Cancer Center)