Pancreatic CancerPhase 1NCT02272738
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
A Phase 1 study testing Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Osaka Medical Center for Cancer and Cardiovascular Diseases at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- 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
- 54 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2013to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced pancreatic cancer
- Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
- Performance Status:0-1(ECOG)
- Patients of age =>20 and 75>
- White Blood Cell (WBC) >=3,500/mm3,12,000/mm3,
- Neutrophils >=1,500/mm3, platelets=100,000/mm3,
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- Hemoglobin >=9.5 g/dl,
- GOT </=2.0 X Upper Limit Number (ULN),
- Glutamate Pyruvate Transaminase (GPT) </=2.0 X ULN,
- Alkaline Phosphatase (ALP) </=2.0 X ULN,
- Total bilirubin <=1.5mg/dl,
- Serum creatinine <=1.2mg/dl,
- Creatinine clearance>=50 ml/min
- arterial O2 pressure (PaO2) >=70torr or arterial O2 saturation (SpO2) >=96%
- Life expectancy more than 3 months.
- Written informed consent.
Who cannot join
- Active infection
- Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
- Severe complication (heart disease, cirrhosis, diabetes)
- Myocardial infarction within 3 months
- Active synchronous or metachronous malignancy
- Pregnant or lactation women, or women with known or suspected pregnancy
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- Symptomatic brain metastasis
- History of severe drug allergy
- Peripheral neuropathy
- Patients who are judged inappropriate for the entry into the study by the investigator
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511
About this study
Official title: A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.
Read the detailed description
Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.
- Conditions
- 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 Gemcitabine ；gemzer
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-PaclitaxelDrug
Also called Nab-Paclitaxel ；Abraxane
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Nab-Paclitaxel | Experimental | A conformal phase I study using 3 plus 3 method.
Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered.
Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm.
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions. Receives: Drug: Gemcitabine; Drug: Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events
Measured: 1 years
Secondary outcomes (2)
Response Rate
Measured: 1 years
Overall Survival time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startAug 2013
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatsuya Ioka, MD, Study director, Osaka Medical Center for Cancer and Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272738
- Sponsor's protocol ID
- TatsuyaIoka2013
- Other IDs
- UMIN 000012254
- Status last verified
- Nov 2017
- First submitted
- 18 Oct 2014
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02272738
- Acronym / sponsor ID
- TatsuyaIoka2013
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Osaka Medical Center for Cancer and Cardiovascular DiseasesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.
Detailed description
Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Nab-Paclitaxel | Experimental | Drug: Gemcitabine, Drug: Nab-PaclitaxelA conformal phase I study using 3 plus 3 method. Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered. Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm. Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed advanced pancreatic cancer
- Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
- Performance Status:0-1(ECOG)
- Patients of age =>20 and 75>
- White Blood Cell (WBC) >=3,500/mm3,12,000/mm3,
Key exclusion criteria (10 listed)
- Active infection
- Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
- Severe complication (heart disease, cirrhosis, diabetes)
- Myocardial infarction within 3 months
- Active synchronous or metachronous malignancy
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: Gemcitabine ；gemzerGemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. | Drug | Gemcitabine, Nab-Paclitaxel |
| Nab-PaclitaxelAlso: Nab-Paclitaxel ；AbraxaneNab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. | Drug | Gemcitabine, Nab-Paclitaxel |
Primary outcome
Number of patients with Adverse Events
Time frame: 1 years
2 secondary outcomes
Response Rate
Time frame: 1 years
Overall Survival time
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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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.
Tatsuya Ioka, MD study director
Osaka Medical Center for Cancer and Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Osaka Medical Center for Cancer and Cardiovascular Diseases at 1 site in Japan.
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 16 inclusion and 10 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 21 Nov 2017. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with Adverse Events (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2017.