Phase 2
N=127
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Metastatic Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02827201 ↗Enrolled (actual)
127
Serious AEs
40.2%
Results posted
Jul 2024
Primary outcome: Primary: Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization — 28; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FOLFIRI.3 (Drug); nab-paclitaxel+ gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Federation Francophone de Cancerologie Digestive
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization |
28; 14 | — |
| SECONDARY Overall Survival (OS): |
11.71; 10.94 | — |
| SECONDARY Best Response |
1; 0; 24; 16; 20; 26 | — |
| SECONDARY Progression-free Survival (PFS) |
5.72; 4.21 | — |
Summary
The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Distant metastatic disease
- Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- At least one lesion measurable by RECIST v1.1 criteria
- Life expectancy> 3 months
- No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
- No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
- Pain must be monitored before inclusion
- 18 years 60 mL/min
- Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
- Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
- Patient affiliated to the social security scheme
- Patient information and signature of informed consent
Exclusion Criteria
- - Other types of pancreatic tumours, especially endocrine or acinar cell tumours
- Ampulloma
- Presence of meningeal or cerebral metastases, bone metastases
- Gilbert's syndrome
- Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
- Contraindications specific to the studied treatments
- History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
- Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
- Significant history of heart or respiratory disease, including any history of interstitial pneumonia
- Patient already included in another clinical trial with an experimental molecule
- Women who are breast-feeding
- Persons deprived of liberty or under guardianship
- Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons
Data sourced from ClinicalTrials.gov (NCT02827201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.