Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abraxane

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Willing and able to comply with the protocol requirement.
Patients must not have any peripheral neuropathy equal or greater than grade 2

Exclusion Criteria:

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.

Sites / Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami
Johns Hopkins Singapore International Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abraxane

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of Participants Showing Stable Disease

Number of participants showing stable disease according to RECIST 1.0 criteria

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.

Number of Participants Experiencing Adverse Events

Median Overall Survival of Participants

Median overall survival rate of participants measured in months

Full Information

NCT ID

NCT00691054

First Posted

June 4, 2008

Last Updated

April 4, 2017

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00691054

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abraxane

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Abraxane

Other Intervention Name(s)

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival Rate at 6 Months

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of Participants Showing Complete or Partial Response

Description

Time Frame

6 months

Title

Number of Participants Showing Stable Disease

Description

Number of participants showing stable disease according to RECIST 1.0 criteria

Time Frame

12 months

Title

Progression-free Survival

Description

Time Frame

6 months

Title

Number of Participants Experiencing Adverse Events

Time Frame

6 months

Title

Median Overall Survival of Participants

Description

Median overall survival rate of participants measured in months

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Willing and able to comply with the protocol requirement. Patients must not have any peripheral neuropathy equal or greater than grade 2 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caio Max S. Rocha Lima, MD

Organizational Affiliation

University of Miami Sylvester Comprehensive Cancer Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gilberto Lopes, MD

Organizational Affiliation

Johns Hopkins Singapore International Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami Sylvester Comprehensive Cancer Center - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Johns Hopkins Singapore International Medical Centre

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

22307213

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs