Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007130

Trial Description

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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

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Trial Acronym

PanaMa

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007130
  •   2014/11/26
  •   2013/10/22
  •   no
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Secondary IDs

  •   2012-005422-30 
  •   NCT01991873  (ClinicalTrials.gov)
  •   AIO-KRK-0212  (AIO-Studien-gGmbH)
  •   2012-005422-30 
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Health Condition or Problem studied

  •   Metastatic Colorectal Cancer
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Drug: Maintenance Chemotherapy
  •   Drug: Panitumumab (Within maintenance phase)
  •   Drug: mFOLFOX6 (Within re-induction phase)
  •   Drug: Panitumumab (Within re-induction phase)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 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.

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/04/30
  •   280
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • AIO-Studien-gGmbH
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    • ClinAssess GmbH
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    • Amgen
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    • Praxis für interdisziplinäre Onkologie & Hämatologie Freiburg
    • Tanja Trarbach, Dr. med. 
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    • Daniela Bein, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   99
  •   2014/10/27
* This entry means the parameter is not applicable or has not been set.