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)

June 13, 2023 updated by: AIO-Studien-gGmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Eschweiler, Germany, 52249
        • St.-Antonius-Hospital Eschweiler
      • Wilhelmshaven, Germany, 26389
        • Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Maintenance Chemotherapy
Other Names:
  • Folinic acid + 5-FU (5-Fluorouracil)
Drug: Panitumumab (Within maintenance phase)
Other Names:
  • Vectibix
Drug: mFOLFOX6 (Within re-induction phase)
Other Names:
  • Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)
Drug: Panitumumab (Within re-induction phase)
Other Names:
  • Vectibix
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
Drug: Maintenance Chemotherapy
Other Names:
  • Folinic acid + 5-FU (5-Fluorouracil)
Drug: mFOLFOX6 (Within re-induction phase)
Other Names:
  • Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)
Drug: Panitumumab (Within re-induction phase)
Other Names:
  • Vectibix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until end of follow-up (24 months after randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until end of follow up (24 months after randomization)
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
From start of re-induction therapy until progress or end of follow-up (24 months after randomization)
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
12 weeks after start 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
Start of maintenance- until end of re-inductin therapy (expected average of 8 months)
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
Until end of follow-up (24 months after randomization)
Safety
Time Frame: Until end of follow-up (24 months after randomization)
Overall safety
Until end of follow-up (24 months after randomization)
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
Until end of follow-up (24 months after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIO-Studien-gGmbH

Collaborators

Amgen
ClinAssess GmbH

Investigators

  • Principal Investigator: Tanja Trarbach, Dr. med., Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 18, 2023

Study Completion (Actual)

February 18, 2023

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimated)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO-KRK-0212
  • 2012-005422-30 (EudraCT Number)
  • PanaMa_DE-2009-0003 (Other Identifier: Amgen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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