Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Did Not Respond to First-Line Therapy With Gemcitabine

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691054
• Other study ID #: UMIAMI-20080055
• Secondary ID: SCCC-2007096
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2008
• Last updated: July 25, 2014
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic cancer

• Locally advanced (unresectable) or metastatic disease

• Must have failed first-line treatment with a gemcitabine hydrochloride-containing regimen

• Measurable or nonmeasurable disease by RECIST criteria

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• Neutrophils = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 9.0 g/dL

• Serum creatinine = 1.5 mg/dL

• Bilirubin = 1.5 times upper limit of normal (ULN)

• ALT and AST = 2.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No peripheral neuropathy = grade 2

• No clinical AIDS or known positive HIV serology

• No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years

• No unstable angina

• No New York Heart Association class II-IV congestive heart failure

• No myocardial infarction within the past 3 months

• No stroke within the past 3 months

• No significant traumatic injury within the past 28 days

• No serious medical or psychiatric illness that would render chemotherapy unsafe

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• More than 3 weeks since prior chemotherapy

• More than 2 weeks since prior radiotherapy

• More than 4 weeks since prior major surgery or open biopsy

• More than 4 weeks since prior experimental drug

• At least 3 weeks since other prior therapy

• No concurrent major surgery

• No concurrent radiotherapy

• No other concurrent chemotherapy, immunotherapy, or antitumor hormonal therapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Singapore	Johns Hopkins Singapore International Medical Centre	Singapore
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Countries where clinical trial is conducted

United States,  Singapore, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months	No
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 Cesponse (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% descrease in the sum of the longest diameter of target lesions; Overal Response (OR) = CR + PR.	6 months	No
Secondary	Number of Participants Showing Stable Disease	Number of participants showing stable disease according to RECIST 1.0 criteria	12 months	No
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.	6 months	No
Secondary	Number of Participants Experiencing Adverse Events		6 months	Yes
Secondary	Median Overall Survival of Participants	Median overall survival rate of participants measured in months	12 months	No