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

Metastatic Colorectal Cancer Clinical Trial

— PanaMa  

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 Details — Status: Completed

Administrative data

• NCT number: NCT01991873
• Other study ID #: AIO-KRK-0212
• Secondary ID: 2012-005422-30Pa
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: February 18, 2023

Study information

• Verified date: June 2023
• Source: AIO-Studien-gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: February 18, 2023
• Est. primary completion date: February 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Maintenance Chemotherapy

• Panitumumab (Within maintenance phase)

• mFOLFOX6 (Within re-induction phase)

• Panitumumab (Within re-induction phase)

Locations

Country	Name	City	State
Germany	St.-Antonius-Hospital Eschweiler	Eschweiler
Germany	Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven	Wilhelmshaven

Sponsors (3)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH	Amgen, ClinAssess GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Homepage of the AIO (Arbeitsgemeinschaft Internistische Onkologie in der Deutschen Krebsgesellschaft e.V.)