Pancreatic Carcinoma MetastaticPhase 2NCT02391662
Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4 and Gemcitabine 1000 weeks 1,2,3/4 in people with Pancreatic Carcinoma Metastatic, run by Asociación de Oncología Médica del Hospital de Cruces at 21 sites in Spain.
Trial summary
Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pancreatic Carcinoma Metastatic
- What is being tested?
- Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4 and Gemcitabine 1000 weeks 1,2,3/4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 21 sitesSpain
- Study dates
- 23 Jun 2015to Mar 2019
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically-confirmed pancreatic adenocarcinoma
- Stage IV disease (metastatic only)
- No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
- ECOG performance status of 0-1
- Age >=70 years.
- Evidence of either or both of the following:
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- RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan)
- An elevated serum CA19-9 at baseline ( >= 2X ULN)
- Female patients must be either surgically sterile or postmenopausal.
- Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
- Adequate bone marrow function:
- ANC >= 1500/uL
- platelet count >= 100,000/uL
- hemoglobin >= 9.0 g/dL
- Adequate hepatic function:
- Total bilirubin <= 1.5 X ULN
- AST (SGOT) <= 2.5 X ULN
- ALT (SGPT) <= 2.5 X ULN
- Adequate renal function as determined by either:
- Serum creatinine <= 1.5 X ULN
- Calculated or measured creatinine clearance >= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
- Ability to understand the nature of this study protocol and give written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Any prior systemic or investigational therapy for metastatic pancreatic cancer.
- Inability to comply with study and/or follow-up procedures.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- Presence of central nervous system or brain metastases.
- Life expectancy < 12 weeks.
- Pregnancy (positive pregnancy test) or lactation.
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- Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy.
- Pre-existing sensory neuropathy > grade 1.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Concurrent/pre-existing use of anticoagulant treatment.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Infanta Cristina
Badajoz, 06080
Hospital Universitario de Cruces
Barakaldo, Gipuzkoa, 48903
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital Universitario de Burgos
Burgos, 09006
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, Murcia, 30120
Ico Girona
Girona, 17007
Hospital General de Granollers
Granollers, Barcelona, 08402
Complejo Hospitalario de Jaén
Jaén, 23007
C. Hospitalario Universitario Insularmaterno-Infantil
Las Palmas de Gran Canaria, 35016
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Hm Sanchinarro
Madrid, 28050
Hospital Quirón Madrid
Madrid, 28223
Centre Hospitalari de Manresa
Manresa, Barcelona, 08240
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Complejo Hospitalario Regional Virgen Macarena
Seville, 41009
Hospital Virgen Del Rocio
Seville, 41013
Hospital Xeral de Vigo
Vigo, Pontevedra, 36204
About this study
Official title: A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Since there is no specific recommendations for treatment of elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of choice for these patients.
Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and targeted agents to gemcitabine has almost invariably provided no significant survival improvement.
Read more
Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in overall survival, but due to in this clinical trial was included patients between 27 and 88 years, it is considered necessary to conduct a specific study for patients over 70 years.
The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel associated with gemcitabine can be extended to elderly patients with pancreatic cancer.
- Conditions
- Pancreatic Carcinoma Metastatic
- Being tested
- Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4, Gemcitabine 1000 weeks 1,2,3/4
- Keywords
- Metastatic Pancreatic Adenocarcinoma, Elderly, Nab-paclitaxel, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4Drug
Also called Nab-paclitaxel
Nab-paclitaxel 125 mg/m2 days 1,8 \& 15 in a 28 days cycle
Gemcitabine 1000 weeks 1,2,3/4Drug
Also called Gemcitabine
Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel plus Gemcitabine | Experimental | Nab-paclitaxel 125 mg/m2 plus Gemcitabine 1000 days 1, 8 \& 15 in a 28 days cycle Receives: Drug: Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4; Drug: Gemcitabine 1000 weeks 1,2,3/4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment through 3-months deterioration free rate
The general deterioration of the patient is assessed with the EORTC-QLQ-C30 scale. t will be considered definitive deterioration a decrease of at least 10 points from baseline. We will evaluate the rate of patients free of definitive deterioration at 3 months.
Measured: Up to 3 months
Secondary outcomes (5)
Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria
Number of events per patient according to NCI-CTC-AE criteria
Measured: Up to 6 months
Time to tumor progression
Time from patient inclusion to disease progression according RECIST criteria
Measured: Up to 8 months
Overall survival
Time from patient inclusion to death
Measured: Up to 12 months
Objective radiographic response (ORR)
Response rate will be evaluated according RECIST criteria
Measured: Up to 6 months
CA 19.9 biomarker response
CA 19.9 biomarker response will be considered a decrease of at least 50% compared to baseline
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start23 Jun 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Carcinoma MetastaticStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación de Oncología Médica del Hospital de Cruces
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L., Celgene
- Responsible party
- Sponsor
- Investigators
- Guillermo López Vivanco, MD, Study chair, Hospital de Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391662
- Sponsor's protocol ID
- BIBABRAX
- Other IDs
- 2014-003596-27, 2014
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02391662
- Acronym / sponsor ID
- BIBABRAX
- Conditions
- Pancreatic Carcinoma Metastatic
- Keywords
- Metastatic Pancreatic Adenocarcinoma, Elderly, Nab-paclitaxel, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asociación de Oncología Médica del Hospital de CrucesUniversity, hospital or other
- Collaborators
- Apices Soluciones S.L., Celgene
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Mar 2015 (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.
Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Since there is no specific recommendations for treatment of elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of choice for these patients.
Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and targeted agents to gemcitabine has almost invariably provided no significant survival improvement.
Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in overall survival, but due to in this clinical trial was included patients between 27 and 88 years, it is considered necessary to conduct a specific study for patients over 70 years.
The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel associated with gemcitabine can be extended to elderly patients with pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel plus Gemcitabine | Experimental | Drug: Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4, Drug: Gemcitabine 1000 weeks 1,2,3/4Nab-paclitaxel 125 mg/m2 plus Gemcitabine 1000 days 1, 8 \& 15 in a 28 days cycle |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (23 listed)
- Histologically or cytologically-confirmed pancreatic adenocarcinoma
- Stage IV disease (metastatic only)
- No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
- ECOG performance status of 0-1
- Age >=70 years.
Key exclusion criteria (13 listed)
- Any prior systemic or investigational therapy for metastatic pancreatic cancer.
- Inability to comply with study and/or follow-up procedures.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- Presence of central nervous system or brain metastases.
- Life expectancy < 12 weeks.
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 |
|---|---|---|
| Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4Also: Nab-paclitaxelNab-paclitaxel 125 mg/m2 days 1,8 \& 15 in a 28 days cycle | Drug | Nab-paclitaxel plus Gemcitabine |
| Gemcitabine 1000 weeks 1,2,3/4Also: GemcitabineGemcitabine 1000 days 1,8 \& 15 in a 28 days cycle | Drug | Nab-paclitaxel plus Gemcitabine |
Primary outcome
Efficacy of treatment through 3-months deterioration free rate
Time frame: Up to 3 months
The general deterioration of the patient is assessed with the EORTC-QLQ-C30 scale. t will be considered definitive deterioration a decrease of at least 10 points from baseline. We will evaluate the rate of patients free of definitive deterioration at 3 months.
5 secondary outcomes
Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria
Time frame: Up to 6 months
Time to tumor progression
Time frame: Up to 8 months
Overall survival
Time frame: Up to 12 months
Objective radiographic response (ORR)
Time frame: Up to 6 months
CA 19.9 biomarker response
Time frame: Up to 6 months
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 28 Aug 2019.
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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.
Guillermo López Vivanco, MD study chair
Hospital de Cruces
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4 and Gemcitabine 1000 weeks 1,2,3/4 in people with Pancreatic Carcinoma Metastatic, run by Asociación de Oncología Médica del Hospital de Cruces at 21 sites in Spain.
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 23 inclusion and 13 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. 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?
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?
Efficacy of treatment through 3-months deterioration free rate (time frame: Up to 3 months). 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 28 Aug 2019.