Pancreatic Carcinoma Non-resectablePhase 2NCT01851174

Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

A Phase 2 study testing Gemcitabine and nab-Paclitaxel in people with Pancreatic Carcinoma Non-resectable and Stage IV Pancreatic Cancer, run by Western Regional Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer
What is being tested?: Gemcitabine and nab-Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jan 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
Patient has one or more radiographically measurable tumor.
Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
Age ≥ 18 years.
Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
ECOG performance status 0 - 2 and an expected survival of at least 3 months.

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Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Hemoglobin (Hgb) ≥ 9g/dl
Patients with adequate organ function as measured by:
Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.
Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.
Women must meet one of the following criteria:
Post-menopausal for at least one year
Surgically incapable of child-bearing
Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.

Who cannot join

Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
Previous use of any chemotherapy or radiation therapy for metastatic disease.
Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
Other significant active or chronic infection.
History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
Pregnant or nursing females.

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Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
Major surgery, other than diagnostic surgery within 4 weeks of study entry.
Patient requires a legal authorized representative for consenting.

Trial locations and contacts

1 site in 1 country.

United States1 site

Western Regional Medical Center
Goodyear, Arizona, 85338

Other trials in United States

About this study

Official title: A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

Read the detailed description

This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Conditions: Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer
Being tested: Gemcitabine, nab-Paclitaxel
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GemcitabineDrug
Also called Gemzar
Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion
nab-PaclitaxelDrug
Also called Abraxane
Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Study groups in NCT01851174
Study group	Role	What they receive
Gemcitabine and nab-Paclitaxel	Experimental	Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days Receives: Drug: Gemcitabine; Drug: nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival Based on Toxicity Profile of Adverse Events.
Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel
Measured: One year

Secondary outcomes (1)

Progression Free Survival Time
Determine progression free survival time with this regimen
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jan 2015

First posted10 May 2013 (estimated)
Study startFeb 2013
Primary completionJan 2015
Study completionJan 2015

Why it stopped: PI Leaving Site

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.
Other trials for Pancreatic Carcinoma Non-resectableStudies of the same condition, open and under way.
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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01851174
Sponsor's protocol ID: WRMC 12-25
Status last verified: Jan 2018
First submitted: 15 Feb 2013
Last updated: 7 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pancreatic Carcinoma Non-resectable trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT01851174
Acronym / sponsor ID: WRMC 12-25
Conditions: Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI Leaving Site
Enrolment: 15 participants (actual)
Lead sponsor: Western Regional Medical CenterUniversity, hospital or other
Study start: Feb 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 10 May 2013 (estimated)
Results: Posted 4 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine and nab-Paclitaxel	Experimental	Drug: Gemcitabine, Drug: nab-PaclitaxelGemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
Patient has one or more radiographically measurable tumor.
Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
Age ≥ 18 years.
Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.

Key exclusion criteria (9 listed)

Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
Previous use of any chemotherapy or radiation therapy for metastatic disease.
Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
Other significant active or chronic infection.
History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.

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
GemcitabineAlso: GemzarPatients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion	Drug	Gemcitabine and nab-Paclitaxel
nab-PaclitaxelAlso: AbraxanePatients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion	Drug	Gemcitabine and nab-Paclitaxel

Primary outcome

Overall Survival Based on Toxicity Profile of Adverse Events.
Time frame: One year
Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel

1 secondary outcome

Progression Free Survival Time
Time frame: One year

Results and safety

Results posted to the registry on 4 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine and Nab-Paclitaxel	15	15

Primary outcome: Overall Survival Based on Toxicity Profile of Adverse Events.

Time frame: One year

Population analysed: The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: There is no information available that reflects this information. The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine and Nab-Paclitaxel	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
CREO - Microwave Ablation Feasibility Study
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RecruitingPhase 1
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Active, not recruitingPhase 1/2
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RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
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RecruitingPhase 2
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial
Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma

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.

Madappa Kundranda, MD, PhD principal investigator

Western Regional Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 4 Dec 2017). 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 Based on Toxicity Profile of Adverse Events. (time frame: One year). 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 NCT01851174.

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 7 Feb 2018.