Pancreatic CancerPhase 2NCT00691054
Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
A Phase 2 study testing Abraxane in people with Pancreatic Cancer, run by University of Miami at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Singapore1 site
Johns Hopkins Singapore International Medical Centre
Singapore, 119074
About this study
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
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.
Read the 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
- Being tested
- Abraxane
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called Paclitaxel Albumin-Stabilized Nanoparticle Formulation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Number of Participants Showing Stable Disease
Number of participants showing stable disease according to RECIST 1.0 criteria
Measured: 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.
Measured: 6 months
Number of Participants Experiencing Adverse Events
Measured: 6 months
Median Overall Survival of Participants
Median overall survival rate of participants measured in months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caio Max S. Rocha Lima, MD, Study chair, University of Miami Sylvester Comprehensive Cancer CenterGilberto Lopes, MD, Principal investigator, Johns Hopkins Singapore International Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691054
- Sponsor's protocol ID
- 20080055
- Other IDs
- SCCC-2007096
- Status last verified
- Apr 2017
- First submitted
- 4 Jun 2008
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 22307213
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00691054
- Acronym / sponsor ID
- 20080055
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 15 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane | Experimental | Drug: AbraxaneOne treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbraxaneAlso: Paclitaxel Albumin-Stabilized Nanoparticle FormulationOne 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 | Drug | Abraxane |
Primary outcome
Overall Survival Rate at 6 Months
Time frame: 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.
5 secondary outcomes
Number of Participants Showing Complete or Partial Response
Time frame: 6 months
Number of Participants Showing Stable Disease
Time frame: 12 months
Progression-free Survival
Time frame: 6 months
Number of Participants Experiencing Adverse Events
Time frame: 6 months
Median Overall Survival of Participants
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22307213Hosein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caio Max S. Rocha Lima, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
Gilberto Lopes, MD principal investigator
Johns Hopkins Singapore International Medical Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane in people with Pancreatic Cancer, run by University of Miami at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Rate at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.