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

NCT ID: NCT00691054

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Abraxane

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caio Max S. Rocha Lima, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Gilberto Lopes, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Singapore International Medical Centre

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Johns Hopkins Singapore International Medical Centre

Singapore, , Singapore

Countries

United States; Singapore

References

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.

Reference Type: RESULT

PMID: 22307213 (View on PubMed)

Other Identifiers

SCCC-2007096

Identifier Type: OTHER

Identifier Source: secondary_id

20080055

Identifier Type: -

Identifier Source: org_study_id