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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 (PanaMa)

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ClinicalTrials.gov Identifier: NCT01991873
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
ClinAssess GmbH
Amgen
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE October 22, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date March 6, 2019
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Progression-free survival [ Time Frame: Until end of follow-up (24 months after randomization) ]
Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01991873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • failure of treatment strategy [ Time Frame: Until end of follow up (24 months after randomization) ]
    Time from randomization until failure (death/ progression) of treatment strategy
  • 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) ]
    Progression-free survival during re-induction therapy
  • Objective response after 12 weeks of induction chemotherapy [ Time Frame: 12 weeks after start of induction chemotherapy ]
    Objective response after 12 weeks of induction chemotherapy
  • Objective best response during maintenance and re-induction [ Time Frame: Start of maintenance- until end of re-inductin therapy (expected average of 8 months) ]
    Objective best response during maintenance and re-induction
  • Overall survival [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall survival measured from time of randomization and from time of registration
  • Safety [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall safety
  • Health and skin related Quality of life [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Health and skin related Quality of life
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • failure of treatment strategy [ Time Frame: Until end of follow up (24 months after randomization) ]
    Time from randomization until failure (death/ progression) of treatment strategy
  • 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) ]
    Progression-free survival during re-induction therapy
  • Objective response after 12 weeks of induction chemotherapy [ Time Frame: 12 weeks after start of induction chemotherapy ]
    Objective response after 12 weeks of induction chemotherapy
  • Objective best response during maintenance and re-induction [ Time Frame: Start of maintenance- until end of re-inductin therapy (expected average of 8 months) ]
    Objective best response during maintenance and re-induction
  • Overall survival [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall survival measured from time of randomization
  • Safety [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall safety
  • Health and skin related Quality of life [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Health and skin related Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Maintenance Chemotherapy
    Other Name: Folinic acid + 5-FU (5-Fluorouracil)
  • Drug: Panitumumab (Within maintenance phase)
    Other Name: Vectibix
  • Drug: mFOLFOX6 (Within re-induction phase)
    Other Name: Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)
  • Drug: Panitumumab (Within re-induction phase)
    Other Name: Vectibix
Study Arms  ICMJE
  • Experimental: Maintenance Chemotherapy + Panitumumab

    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

    Interventions:
    • Drug: Maintenance Chemotherapy
    • Drug: Panitumumab (Within maintenance phase)
    • Drug: mFOLFOX6 (Within re-induction phase)
    • Drug: Panitumumab (Within re-induction phase)
  • Experimental: Maintenance Chemotherapy w/o Panitumumab

    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

    Interventions:
    • Drug: Maintenance Chemotherapy
    • Drug: mFOLFOX6 (Within re-induction phase)
    • Drug: Panitumumab (Within re-induction phase)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
380
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
280
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniela Bein, Dr. d.bein@clinassess.de
Contact: Helge Schröder, Dipl.Biol. Helge.Schroeder@aio-studien-ggmbh.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01991873
Other Study ID Numbers  ICMJE AIO-KRK-0212
2012-005422-30 ( EudraCT Number )
PanaMa_DE-2009-0003 ( Other Identifier: Amgen )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE
  • ClinAssess GmbH
  • Amgen
Investigators  ICMJE
Principal Investigator: Tanja Trarbach, Dr. med. Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven
PRS Account AIO-Studien-gGmbH
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP