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

Federation Francophone de Cancerologie Digestive

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: nab-paclitaxel+ gemcitabine; Drug: FOLFIRI.3

Study type: Interventional

Funder types: Other

Identifiers

NCT02827201

PRODIGE 37

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

nab-paclitaxel + gemcitabine/FOLFIRI.3

Experimental group

Description:

Alternance of : * 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) * follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression

Treatment:

Drug: nab-paclitaxel+ gemcitabine

Drug: FOLFIRI.3

nab-paclitaxel + gemcitabine

Active Comparator group

Description:

nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression

Treatment:

Drug: nab-paclitaxel+ gemcitabine