A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer

Sponsor
Per Pfeiffer
Study ID
NCT01042028
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus, Cetuximab, Irinotecan — DRUG
    Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
  • Capecitabine, Oxaliplatine — DRUG
    Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly

Study Details

This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.

Key Dates

Start date
Jan 31, 2010
Status verified
Oct 2015
Primary completion
Nov 30, 2012
Completion
Jan 31, 2014

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Phase II: Arm A
    Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
  • Active Comparator: Arm B
    Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.

Primary Outcome Measure

Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) [ Time Frame: 4 months ]

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