Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Panitumumab

Vitamin B Complex

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Maintenance therapy:

Panitumumab 6 mg/kg prior to administration of chemotherapy Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Re-induction upon progression:

Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy.

mFOLFOX6: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Maintenance therapy:

Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Re-induction upon progression:

Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy.

mFOLFOX6 chemotherapy: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Maintenance Chemotherapy

Panitumumab (Within maintenance phase)

mFOLFOX6 (Within re-induction phase)

Panitumumab (Within re-induction phase)

Tanja Trarbach, Dr. med.

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy.

Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.

Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer

Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer

Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.

Time from randomization until failure (death/ progression) of treatment strategy

Progression-free survival during re-induction therapy

Objective response after 12 weeks of induction chemotherapy

Objective best response during maintenance and re-induction

Overall survival measured from time of randomization and from time of registration

ClinAssess GmbH

Amgen

AIO-Studien-gGmbH

Spots Global Cancer Trial Database for panitumumab (within maintenance phase)