Pancreatic Metastatic CancerPhase 2PAMELA70NCT02143219
Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer
A Phase 2 study testing Oxaliplatine, Folinic acid and Irinotecan in people with Pancreatic Metastatic Cancer and Toxicity, run by Institut Cancerologie de l'Ouest at 6 sites in France.
Trial summary
Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per year). The median age at diagnosis is 69 and 74 in male and female respectively. When the 5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20 years, the onset of gemcitabine in 1995 has… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pancreatic Metastatic Cancer, Toxicity
- What is being tested?
- Oxaliplatine, Folinic acid and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesFrance
- Study dates
- 31 Jul 2014to 25 Nov 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically proven ductal pancreatic carcinoma
- Metastatic disease
- First-line treatment : No previous chemotherapy in metastatic stage but adjuvant treatment before relapse (secondary metastatic) is permitted, provide it has been administered more than 6 months before)
- Age of 70 yo or above
- Normal DPD enzyme level or partial defect (excluding total defect)
- Adequate bone marrow reserve: as indicated by : neutrophils >1500/mm3, platelets >100,000/ mm3, Hb >10.0g/dL.
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- Adequate Renal function as indicated by: MDRD creatinine clearance > 50ml/min.
- Adequate hepatic function as indicated by: serum bilirubin < 1.5 times the upper limit of normal, AST and ALT < 2.5 times the upper limit of normal, or < 5 times the upper limit of normal if liver metastases are present.
- Written informed consent must be obtained prior to protocol-specific procedures are being performed
- Patient is affiliated to a social security category
Who cannot join
- Other than ductal pancreatic carcinoma: namely endocrin tumors, acinar cells carcinoma, cystadenocarcinoma or adenocarcinoma of the ampulla of vater
- Non-metastatic but locally advanced pancreatic adenocarcinoma
- Complete DPD deficiency
- History of Cardiac failure or symptomatic coronary artery disease
- Autonomy Daily Living score by Katz <4
- Prior treatment with FOLFIRINOX (adjuvant)
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- Major comorbidity likely to be an obstacle to treatment
- Active or uncontrolled infection such as HIV or chronic B or C hepatitis
- Uncontrolled diabetes mellitus
- Prior peripheral neuropathy, grade > 2
- Inflammatory bowel disease localized on the colon or rectum; bowel obstruction or severe uncontrolled diarrhea
- Previous or concomitant malignancies other than effectively treated carcinoma in situ of the cervix or non-melanoma skin cancer
- Hereditary fructose intolerance
- Persons deprived of liberty or under guardianship
- Any social, geographical or psychological condition which would compromise the ability to fully comply with the trial procedures and treatments
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
ICO Paul Papin
Angers, 49000
CH Vendée
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, 59020
ICM (Val d'Aurelle)
Montpellier, 34298
Centre Eugène marquis
Rennes, 35042
ICO René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Phase-2 Study Evaluating Overall Response Rate (Efficacy) and Autonomy Daily Living Preservation (Tolerance) of "FOLFIRINOX " Pharmacogenetic Dose Adjusted, in Elderly Patients (70 yo. or Older) With a Metastatic Pancreatic Adenocarcinoma.
Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per year). The median age at diagnosis is 69 and 74 in male and female respectively. When the 5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20 years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a phase II followed by a phase-III study, a French collaborative group has demonstrated the benefit of "FOLFIRINOX " regimen versus gemcitabine alone, in terms of median survival (11.1 versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate (31.6 versus 9.4%).
Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was acceptable as a new standard regimen for the majority of patients under the age of 70 with a good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (> 70 yo), pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may be easily performed. The methodology of the study is to use the Bryant \& Day statistical method, allowing to consider simultaneously as principal objective, the response rate (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this design is particularly fitting in a study for elderly patients who represent half of the pancreatic carcinoma population.
Read the detailed description
METHODOLOGY :
Phase II study, opened, multicentric
MAIN OBJECTIVE :
The main objective is the simultaneous evaluation of the objective rate of answer and toxicity of her(it) of the protocol FOLFIRINOX administered to doses adapted at patients of 70 and more years old.
SECONDARY OBJECTIVE :
- Efficiency evaluation;
- Tolerance evaluation;
- Quality of Life (QoL) and clinical profit.
STATISTICAL ANALYSIS:
An analysis in two stages is planned, according to the method of Bryant and Day with a risk ß 5 % to reject wrongly an effective treatment and of acceptable toxicity and a risk a=10 % to accept wrongly a not rather effective or too toxic treatment.
The study will be considered as successful if:
- we obtain at least 11 tumoral answers and
- maxi 30 patients on 72 are in loss of autonomy (decrease of their ADL).
- All the patients who will have received at least an injection will be eligible for the evaluation of the toxicity
- The evaluation of the efficiency will be made after 3 cures at least unless early termination where the scanner will be anticipated.
- All the toxicity will be increased according to criteria of toxicity NCI-CTC v4.0.
- The evaluation of the tumoral answer (CR, PR and SD) will be made according to the criteria RECIST-v1.1.
- Conditions
- Pancreatic Metastatic Cancer, Toxicity
- Being tested
- Oxaliplatine, Folinic acid, Irinotecan, 5-FU
- Keywords
- Pancreatic metastatic cancer, FOLFIRINOX, toxicity, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatineDrug
Also called Eloxatine®
Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acidDrug
Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
IrinotecanDrug
Also called Campto®
Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
- Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
- Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FUDrug
Also called 5-fluorouracile
5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
- If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
- If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Other | FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU Receives: Drug: Oxaliplatine; Drug: Folinic acid; Drug: Irinotecan; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety and Early Efficacy Assessment in the First 34 Patients
This outcome is a composite assessment combining safety and early efficacy signals in the first 34 enrolled patients. Safety is measured by the occurrence of grade ≥3 toxicities (NCI-CTCAE v4.0). Early efficacy is assessed by the presence or absence of tumor response according to predefined stopping rules. Both components contribute jointly to the decision-making criteria for continuation of the study. This description corresponds specifically to the data reported in the Results section.
Measured: From treatment initiation through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start31 Jul 2014
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
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 Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine HIRET, MD, Principal investigator, Institut de Cancérologie de l'Ouest (ICO) - Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143219
- Sponsor's protocol ID
- ICO-N-2014-01
- Other IDs
- 2014-000539-17, 2014
- Acronym
- PAMELA70
- Status last verified
- Mar 2026
- First submitted
- 14 May 2014
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-2 Study Evaluating Overall Response Rate (Efficacy) and Autonomy Daily Living Preservation (Tolerance) of "FOLFIRINOX " Pharmacogenetic Dose Adjusted, in Elderly Patients (70 yo. or Older) With a Metastatic Pancreatic Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT02143219
- Acronym / sponsor ID
- PAMELA70 / ICO-N-2014-01
- Conditions
- Pancreatic Metastatic Cancer, Toxicity
- Keywords
- Pancreatic metastatic cancer, FOLFIRINOX, toxicity, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per year). The median age at diagnosis is 69 and 74 in male and female respectively. When the 5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20 years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a phase II followed by a phase-III study, a French collaborative group has demonstrated the benefit of "FOLFIRINOX " regimen versus gemcitabine alone, in terms of median survival (11.1 versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate (31.6 versus 9.4%).
Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was acceptable as a new standard regimen for the majority of patients under the age of 70 with a good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (> 70 yo), pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may be easily performed. The methodology of the study is to use the Bryant \& Day statistical method, allowing to consider simultaneously as principal objective, the response rate (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this design is particularly fitting in a study for elderly patients who represent half of the pancreatic carcinoma population.
Detailed description
METHODOLOGY :
Phase II study, opened, multicentric
MAIN OBJECTIVE :
The main objective is the simultaneous evaluation of the objective rate of answer and toxicity of her(it) of the protocol FOLFIRINOX administered to doses adapted at patients of 70 and more years old.
SECONDARY OBJECTIVE :
- Efficiency evaluation;
- Tolerance evaluation;
- Quality of Life (QoL) and clinical profit.
STATISTICAL ANALYSIS:
An analysis in two stages is planned, according to the method of Bryant and Day with a risk ß 5 % to reject wrongly an effective treatment and of acceptable toxicity and a risk a=10 % to accept wrongly a not rather effective or too toxic treatment.
The study will be considered as successful if:
- we obtain at least 11 tumoral answers and
- maxi 30 patients on 72 are in loss of autonomy (decrease of their ADL).
- All the patients who will have received at least an injection will be eligible for the evaluation of the toxicity
- The evaluation of the efficiency will be made after 3 cures at least unless early termination where the scanner will be anticipated.
- All the toxicity will be increased according to criteria of toxicity NCI-CTC v4.0.
- The evaluation of the tumoral answer (CR, PR and SD) will be made according to the criteria RECIST-v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Other | Drug: Oxaliplatine, Drug: Folinic acid, Drug: Irinotecan, Drug: 5-FUFOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Histologically proven ductal pancreatic carcinoma
- Metastatic disease
- First-line treatment : No previous chemotherapy in metastatic stage but adjuvant treatment before relapse (secondary metastatic) is permitted, provide it has been administered more than 6 months before)
- Age of 70 yo or above
- Normal DPD enzyme level or partial defect (excluding total defect)
Key exclusion criteria (15 listed)
- Other than ductal pancreatic carcinoma: namely endocrin tumors, acinar cells carcinoma, cystadenocarcinoma or adenocarcinoma of the ampulla of vater
- Non-metastatic but locally advanced pancreatic adenocarcinoma
- Complete DPD deficiency
- History of Cardiac failure or symptomatic coronary artery disease
- Autonomy Daily Living score by Katz <4
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 |
|---|---|---|
| OxaliplatineAlso: Eloxatine®Oxaliplatine : 85mg/m², 2-hours IV infusion (D1), | Drug | FOLFIRINOX |
| Folinic acidFolinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1), | Drug | FOLFIRINOX |
| IrinotecanAlso: Campto®Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts * Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max. * Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance. | Drug | FOLFIRINOX |
| 5-FUAlso: 5-fluorouracile5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion: * If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one * If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course. | Drug | FOLFIRINOX |
Primary outcome
Composite Safety and Early Efficacy Assessment in the First 34 Patients
Time frame: From treatment initiation through Week 12
This outcome is a composite assessment combining safety and early efficacy signals in the first 34 enrolled patients. Safety is measured by the occurrence of grade ≥3 toxicities (NCI-CTCAE v4.0). Early efficacy is assessed by the presence or absence of tumor response according to predefined stopping rules. Both components contribute jointly to the decision-making criteria for continuation of the study. This description corresponds specifically to the data reported in the Results section.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sandrine HIRET, MD principal investigator
Institut de Cancérologie de l'Ouest (ICO) - Nantes, France
6 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 Oxaliplatine, Folinic acid and Irinotecan in people with Pancreatic Metastatic Cancer and Toxicity, run by Institut Cancerologie de l'Ouest at 6 sites in France.
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 10 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 Apr 2026). 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?
Composite Safety and Early Efficacy Assessment in the First 34 Patients (time frame: From treatment initiation through Week 12). 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 15 Apr 2026.