Clinical Trials /

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

NCT01991873

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: AIO-KRK-0212
  • SECONDARY ID: 2012-005422-30
  • SECONDARY ID: PanaMa_DE-2009-0003
  • NCT ID: NCT01991873

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
Maintenance ChemotherapyFolinic acid + 5-FU (5-Fluorouracil)Maintenance Chemotherapy + Panitumumab
Panitumumab (Within maintenance phase)VectibixMaintenance Chemotherapy + Panitumumab
mFOLFOX6 (Within re-induction phase)Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)Maintenance Chemotherapy + Panitumumab
Panitumumab (Within re-induction phase)VectibixMaintenance Chemotherapy + Panitumumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Maintenance Chemotherapy + PanitumumabExperimentalMaintenance 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 Chemotherapy
  • Panitumumab (Within maintenance phase)
  • mFOLFOX6 (Within re-induction phase)
  • Panitumumab (Within re-induction phase)
Maintenance Chemotherapy w/o PanitumumabExperimentalMaintenance 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
  • mFOLFOX6 (Within re-induction phase)
  • Panitumumab (Within re-induction phase)

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent

          -  Male or female ≥ 18 years of age

          -  Histologically proven metastatic colorectal cancer

          -  Molecular testing showing RAS wild-type in colorectal carcinoma cells

          -  Life expectancy > 12 weeks

          -  At least one measurable lesion according to RECIST 1.1

          -  Adequate bone marrow, liver, kidney, organ and metabolic function

          -  Bone marrow function:

               -  leukocyte count ≥ 3.0 × 109/L

               -  ANC ≥ 1.5 × 109/L

               -  platelet count ≥ 100 × 109/L

               -  hemoglobin ≥ 9 g/dL or 5.59 mmol/L (may be transfused or treated with
                  erythropoietin to maintain/ exceed this level)

          -  Hepatic function:

               -  Total bilirubin ≤ 1.5 × UNL

               -  ALT and AST ≤ 2.5 × UNL (or ≤ 5 × UNL in presence of liver metastases)

               -  AP ≤ 5 × UNL

          -  Renal function:

               -  Creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula or serum
                  creatinine ≤ 1.5 × UNL

          -  Metabolic function:

               -  Magnesium ≥ lower limit of normal

               -  Calcium ≥ lower limit of normal

          -  ECOG performance status 0 - 1

          -  Women of child-bearing potential must have a negative pregnancy test

        Exclusion Criteria:

          -  Previous treatment for colorectal cancer in the metastatic setting

          -  Previous EGFR-targeting therapy < 6 months after end of adjuvant therapy

          -  Known brain metastases unless adequately treated (surgery or radiotherapy) with no
             evidence of progression and neurologically stable off anticonvulsants and steroids

          -  Chronic inflammatory bowel disease

          -  Peripheral neuropathy ≥ NCI-CTCAE V 4.03 grade 2

          -  Other previous malignancies with the exception of a history of previous curatively
             treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or
             other curatively treated malignant disease without recurrence after at least 5 years
             of follow-up

          -  Significant disease that, in the investigator's opinion, would exclude the patient
             from the study

          -  History of cardiac disease; defined as:

               -  Congestive heart failure > New York Heart Association (NYHA) class 2

               -  Active coronary artery disease (myocardial infarction more than 6 months prior to
                  start of study treatment is allowed)

               -  Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin
                  are permitted)

               -  Uncontrolled hypertension (defined as blood pressure ≥ 160 mmHg systolic and/or ≥
                  90 mmHg diastolic on medication)

          -  Patients with interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or
             evidence of interstitial lung disease on baseline chest CT scan

          -  Known HIV, hepatitis B or C infection

          -  Known hypersensitivity reaction to any of the study components

          -  Radiotherapy, major surgery or any investigational drug 30 days before registration

          -  Pregnancy or lactation or planning to be pregnant during treatment and within 6 months
             after the end of treatment

          -  Subject (male or female) is not willing to use highly effective methods of
             contraception (per institutional standard) during treatment and for at least an
             additional 6 months after the end of treatment

          -  Known alcohol or drug abuse

          -  Any condition that is unstable or could jeopardize the safety of the patient and his
             compliance in the study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:Until end of follow-up (24 months after randomization)
Safety Issue:
Description:Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.

Secondary Outcome Measures

Measure:failure of treatment strategy
Time Frame:Until end of follow up (24 months after randomization)
Safety Issue:
Description:Time from randomization until failure (death/ progression) of treatment strategy
Measure:Progression-free survival of re-induction
Time Frame:From start of re-induction therapy until progress or end of follow-up (24 months after randomization)
Safety Issue:
Description:Progression-free survival during re-induction therapy
Measure:Objective response after 12 weeks of induction chemotherapy
Time Frame:12 weeks after start of induction chemotherapy
Safety Issue:
Description:Objective response after 12 weeks of induction chemotherapy
Measure:Objective best response during maintenance and re-induction
Time Frame:Start of maintenance- until end of re-inductin therapy (expected average of 8 months)
Safety Issue:
Description:Objective best response during maintenance and re-induction
Measure:Overall survival
Time Frame:Until end of follow-up (24 months after randomization)
Safety Issue:
Description:Overall survival measured from time of randomization and from time of registration
Measure:Safety
Time Frame:Until end of follow-up (24 months after randomization)
Safety Issue:
Description:Overall safety
Measure:Health and skin related Quality of life
Time Frame:Until end of follow-up (24 months after randomization)
Safety Issue:
Description:Health and skin related Quality of life

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AIO-Studien-gGmbH

Trial Keywords

  • metastatic colorectal cancer
  • maintenance therapy
  • Panitumumab
  • Vectibix®

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