Pancreatic NeoplasmsPhase 3NCT01121848
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
A Phase 3 study testing Leucovorin, OXALIPLATIN and 5-Fluorouracil in people with Pancreatic Neoplasms, run by Sanofi at 15 sites in Canada.
Trial summary
Primary Objective: To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death Secondary Objective: To evaluate other measures of tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Leucovorin, OXALIPLATIN and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 15 sitesCanada
- Study dates
- Jul 2010to Oct 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven pancreatic carcinoma
- Measurable locally advanced or metastatic disease
- Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved
- Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
- Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
- Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic Resonance Imaging (MRI) within 4 weeks prior to randomization
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- Adequate liver and kidney function:
- Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)
- Creatinine clearance (ClCr) superior than 50 mL / min
- Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST inferior than 5 ULN if liver metastasis
- Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT inferior than 5 ULN if liver metastasis
- Adequate hematological function:
- Neutrophils superior or egal to 1.5 x 109/L
- Platelets superior or egal to 100 x 109/L
Who cannot join
- Peripheral sensory or motor neuropathy > grade 1
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
- Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
- Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
- Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
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- History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or to any ingredients in the formulations or the containers
- Severe renal impairment (ClCr < 50 mL/min)
- Pregnant women or breast-feeding
- Patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of "effective method of contraception" will be based on the investigators' judgment)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Investigational Site Number 124015
Abbotsford British Columbia, V2S0C2
Investigational Site Number 124018
Brampton, L6V1B4
Investigational Site Number 124014
Burnaby, V5G2X6
Investigational Site Number 124006
Calgary, T2N 4N2
Investigational Site Number 124008
Greater Sudbury, P3E5J1
Investigational Site Number 124011
Greenfield Park, J4V2H1
Investigational Site Number 124010
Hamilton, L8V5C2
Investigational Site Number 124-016
New Glasgow
Investigational Site Number 124013
Oshawa, L1G2B9
Investigational Site Number 124012
Ottawa, K1Y0W9
Investigational Site Number 124004
Sherbrooke, J1H 5N4
Investigational Site Number 124007
Surrey, V3V1Z2
Investigational Site Number 124003
Toronto, M4N3M5
Investigational Site Number 124002
Toronto, M5G2M9
Investigational Site Number 124001
Vancouver, N5Z4E6
About this study
Official title: A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy
Primary Objective:
To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death
Secondary Objective:
To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Leucovorin, OXALIPLATIN, 5-Fluorouracil
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucovorinDrug
Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV
Dose regimen:
OXALIPLATINDrug
Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV
Dose regimen:
5-FluorouracilDrug
Pharmaceutical form: vials of 5 g/100mL Route of administration: IV
Dose regimen:
| Study group | Role | What they receive |
|---|---|---|
| 5-FU & LV | Active comparator | * Day 1: LV 400 mg/m2 (given as a 2-hour infusion)
* Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours.
* This chemotherapy regimen will be administered each two weeks. Receives: Drug: Leucovorin; Drug: 5-Fluorouracil |
| XELOX or modified FOLFOX-6 | Experimental | XELOX:
* Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion)
* This chemotherapy regimen will be administered each two weeks.
OR modified FOLFOX-6:
* Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion)
* Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin)
* Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2)
* This chemotherapy regimen will be administered each two weeks. Receives: Drug: Leucovorin; Drug: OXALIPLATIN; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
Measured: Within the 3 months of study treatment
Secondary outcomes (4)
Overall response rate (ORR)
ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).
Measured: 12 weeks
Duration of response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence, i.e. progressive disease (PD) is determined by RECIST criteria or death
Measured: 12 weeks
Disease Controlled Rate (DCR)
DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)
Measured: 12 weeks
Median Overall Survival (OS)
Median Survival is the number of weeks at which 50% of the patients are still alive.
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 posted12 May 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121848
- Sponsor's protocol ID
- OXALI_L_04918
- Other IDs
- U1111-1116-9746
- Status last verified
- Oct 2014
- First submitted
- 29 Apr 2010
- Last updated
- 27 Oct 2014
- Results posted
- No
Publications
Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.
PubMed 27621395
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01121848
- Acronym / sponsor ID
- OXALI_L_04918
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 May 2010 (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.
Primary Objective:
To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death
Secondary Objective:
To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-FU & LV | Active comparator | Drug: Leucovorin, Drug: 5-Fluorouracil* Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks. |
| XELOX or modified FOLFOX-6 | Experimental | Drug: Leucovorin, Drug: OXALIPLATIN, Drug: 5-FluorouracilXELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2) * This chemotherapy regimen will be administered each two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically proven pancreatic carcinoma
- Measurable locally advanced or metastatic disease
- Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved
- Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
- Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
Key exclusion criteria (11 listed)
- Peripheral sensory or motor neuropathy > grade 1
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
- Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
- Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
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 |
|---|---|---|
| LeucovorinPharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen: | Drug | 5-FU & LV, XELOX or modified FOLFOX-6 |
| OXALIPLATINPharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen: | Drug | XELOX or modified FOLFOX-6 |
| 5-FluorouracilPharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen: | Drug | 5-FU & LV, XELOX or modified FOLFOX-6 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Within the 3 months of study treatment
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
4 secondary outcomes
Overall response rate (ORR)
Time frame: 12 weeks
Duration of response
Time frame: 12 weeks
Disease Controlled Rate (DCR)
Time frame: 12 weeks
Median Overall Survival (OS)
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 27 Oct 2014.
- Derived from this study: PubMed 27621395Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.
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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.
Clinical Sciences & Operations study director
Sanofi
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leucovorin, OXALIPLATIN and 5-Fluorouracil in people with Pancreatic Neoplasms, run by Sanofi at 15 sites in Canada.
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 14 inclusion and 11 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-Free Survival (PFS) (time frame: Within the 3 months of study treatment). 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 NCT01121848, 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 27 Oct 2014.