FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

• Status: Active, not recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR); UNICANCER
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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 < age < 75

• Performance status: WHO < 2

• ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL

• ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found

• Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 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