NCT00691054

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 2008

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 15, 2013

Completed
Last Updated

May 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

June 4, 2008

Results QC Date

September 3, 2013

Last Update Submit

April 4, 2017

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Participants Showing Complete or Partial Response

    6 months

  • Number of Participants Showing Stable Disease

    12 months

  • Progression-free Survival

    6 months

  • Number of Participants Experiencing Adverse Events

    6 months

  • Median Overall Survival of Participants

    12 months

Study Arms (1)

Abraxane

EXPERIMENTAL

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

Interventions

AbraxaneDRUG

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

Also known as: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Abraxane

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
  • Patients have to be 18 years-old or older
  • Able to give signed Informed consent
  • 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
  • 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
  • Measurable or non-measurable disease by RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
  • Life expectancy greater than 3 months
  • +2 more criteria

You may not qualify if:

  • Chemotherapy within 3 weeks prior to enrollment
  • Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
  • Any major surgery within 4 weeks prior to enrollment
  • Peripheral neuropathy equal to or greater than grade 2
  • Clinical AIDS or known positive HIV serology
  • 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
  • Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 3 months
  • History of stroke within 3 months
  • 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
  • Pregnant (positive pregnancy test) or lactating
  • Inability to comply with study and/or follow-up procedures
  • Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
  • Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Johns Hopkins Singapore International Medical Centre

Singapore, 119074, Singapore

Location

Related 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(2):151-6. doi: 10.1097/COC.0b013e3182436e8c.

    PMID: 22307213RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound PaclitaxelTaxes

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsEconomicsHealth Care Economics and Organizations

Results Point of Contact

Title
Caio Max Rocha Lima MD
Organization
University of Miami Sylvester Comprehensive Cancer Center
crocha@med.miami.edu
305-243-7770

Study Officials

  • Caio Max S. Rocha Lima, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

  • Gilberto Lopes, MD

    Johns Hopkins Singapore International Medical Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 5, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 11, 2017

Results First Posted

November 15, 2013

Record last verified: 2017-04

Locations

US(1)SG(1)