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Metastatic Colorectal CancerPhase 2PanaMaNCT01991873

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

A Phase 2 study testing Maintenance Chemotherapy, Panitumumab (Within maintenance phase) and mFOLFOX6 (Within re-induction phase) in people with Metastatic Colorectal Cancer, run by AIO-Studien-gGmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Maintenance Chemotherapy, Panitumumab (Within maintenance phase) and mFOLFOX6 (Within re-induction phase)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
2 sitesGermany
Study dates
Apr 2014to 18 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • St.-Antonius-Hospital Eschweiler

    Eschweiler, 52249

  • Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven

    Wilhelmshaven, 26389

Other trials in Germany

About this study

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

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.

Being tested
Maintenance Chemotherapy, Panitumumab (Within maintenance phase), mFOLFOX6 (Within re-induction phase), Panitumumab (Within re-induction phase)
Keywords
metastatic colorectal cancer, maintenance therapy, Panitumumab, Vectibix®
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintenance ChemotherapyDrug

    Also called Folinic acid + 5-FU (5-Fluorouracil)

  • Panitumumab (Within maintenance phase)Drug

    Also called Vectibix

  • mFOLFOX6 (Within re-induction phase)Drug

    Also called Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)

  • Panitumumab (Within re-induction phase)Drug

    Also called Vectibix

Study groups in NCT01991873
Study groupRoleWhat they receive
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
Receives: Drug: Maintenance Chemotherapy; Drug: Panitumumab (Within maintenance phase); Drug: mFOLFOX6 (Within re-induction phase); Drug: 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
Receives: Drug: Maintenance Chemotherapy; Drug: mFOLFOX6 (Within re-induction phase); Drug: Panitumumab (Within re-induction phase)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.

    Measured: Until end of follow-up (24 months after randomization)

Secondary outcomes (7)

  1. failure of treatment strategy

    Time from randomization until failure (death/ progression) of treatment strategy

    Measured: Until end of follow up (24 months after randomization)

  2. Progression-free survival of re-induction

    Progression-free survival during re-induction therapy

    Measured: From start of re-induction therapy until progress or end of follow-up (24 months after randomization)

  3. Objective response after 12 weeks of induction chemotherapy

    Objective response after 12 weeks of induction chemotherapy

    Measured: 12 weeks after start of induction chemotherapy

  4. Objective best response during maintenance and re-induction

    Objective best response during maintenance and re-induction

    Measured: Start of maintenance- until end of re-inductin therapy (expected average of 8 months)

  5. Overall survival

    Overall survival measured from time of randomization and from time of registration

    Measured: Until end of follow-up (24 months after randomization)

  6. Safety

    Overall safety

    Measured: Until end of follow-up (24 months after randomization)

  7. Health and skin related Quality of life

    Health and skin related Quality of life

    Measured: Until end of follow-up (24 months after randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startApr 2014
  3. Primary completion18 Feb 2023
  4. Study completion18 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01991873
Sponsor's protocol ID
AIO-KRK-0212
Other IDs
2012-005422-30, PanaMa_DE-2009-0003
Acronym
PanaMa
Status last verified
Jun 2023
First submitted
22 Oct 2013
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Stahler A, Modest DP, Stintzing S, Borelli B, Keller T, Held S, Fischer von Weikersthal L, Muller L, Graeven U, Decker T, Heintges T, Kahl C, Hoppe B, Kiani A, Kaiser F, Schwaner I, Fruehauf S, Karthaus M, Trarbach T, Klauschen F, Horst D, Cremolini C, Heinemann V. Individual Patient Data Meta-Analysis of Consensus Molecular Subtypes as Biomarkers of First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer. J Clin Oncol. 2026 Jan;44(1):31-41. doi: 10.1200/JCO-25-00596. Epub 2025 Nov 18.

    PubMed 41252656

  • Ballhausen A, Swoboda S, Horst D, Fruehauf S, Graeven U, Muller L, Trarbach T, Fischer von Weikersthal L, Goekkurt E, Heinemann V, Kasper S, Kurreck A, Alig AHS, Reinacher-Schick AC, Bullinger L, Stahler A, Stintzing S, Jarosch A, Modest DP. Spatial Tumor Immune Microenvironment as a Prognostic and Predictive Biomarker in Anti-EGFR-Based Maintenance for RAS wt Metastatic CRC-The PanaMa (AIO KRK0212) Trial. Clin Cancer Res. 2025 Oct 1;31(19):4049-4058. doi: 10.1158/1078-0432.CCR-25-0879.

    PubMed 40736443

  • Stahler A, Karthaus M, Fruehauf S, Graeven U, Muller L, Fischer von Weikersthal L, Caca K, Goekkurt E, Ballhausen A, Sommerhauser G, Alig AHS, Held S, Jarosch A, Horst D, Reinacher-Schick A, Kasper S, Heinemann V, Stintzing S, Trarbach T, Modest DP. Panitumumab plus 5-fluorouracil and folinic acid or 5-fluorouracil and folinic acid alone as maintenance therapy in RAS wild-type metastatic colorectal cancer (PanaMa, AIO KRK 0212): final efficacy analysis of a randomised, open-label, phase 2 trial. EClinicalMedicine. 2024 Dec 16;79:103004. doi: 10.1016/j.eclinm.2024.103004. eCollection 2025 Jan.

    PubMed 39802302

  • Stahler A, Kind AJ, Sers C, Mamlouk S, Muller L, Karthaus M, Fruehauf S, Graeven U, Fischer von Weikersthal L, Sommerhauser G, Kasper S, Hoppe B, Kurreck A, Held S, Heinemann V, Horst D, Jarosch A, Stintzing S, Trarbach T, Modest DP. Negative Hyperselection of Resistance Mutations for Panitumumab Maintenance in RAS Wild-Type Metastatic Colorectal Cancer (PanaMa Phase II Trial, AIO KRK 0212). Clin Cancer Res. 2024 Apr 1;30(7):1256-1263. doi: 10.1158/1078-0432.CCR-23-3023.

    PubMed 38289994

  • Ballhausen A, Karthaus M, Fruehauf S, Graeven U, Muller L, Konig AO, von Weikersthal LF, Sommerhauser G, Alig AHS, Goekkurt E, Meyer-Knees JW, Kurreck A, Stahler A, Held S, Kasper S, Heinrich K, Heinemann V, Stintzing S, Trarbach T, Modest DP. Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with fluorouracil and folinic acid with or without panitumumab as maintenance therapy: a prespecified secondary analysis of the PanaMa (AIO KRK 0212) trial. Eur J Cancer. 2023 Sep;190:112955. doi: 10.1016/j.ejca.2023.112955. Epub 2023 Jun 28.

    PubMed 37454537

  • Stahler A, Hoppe B, Na IK, Keilholz L, Muller L, Karthaus M, Fruehauf S, Graeven U, Fischer von Weikersthal L, Goekkurt E, Kasper S, Kind AJ, Kurreck A, Alig AHS, Held S, Reinacher-Schick A, Heinemann V, Horst D, Jarosch A, Stintzing S, Trarbach T, Modest DP. Consensus Molecular Subtypes as Biomarkers of Fluorouracil and Folinic Acid Maintenance Therapy With or Without Panitumumab in RAS Wild-Type Metastatic Colorectal Cancer (PanaMa, AIO KRK 0212). J Clin Oncol. 2023 Jun 1;41(16):2975-2987. doi: 10.1200/JCO.22.02582. Epub 2023 Apr 5.

    PubMed 37018649

  • Sommerhauser G, Kurreck A, Beck A, Fehrenbach U, Karthaus M, Fruehauf S, Graeven U, Mueller L, Koenig AO, V Weikersthal LF, Goekkurt E, Haas S, Stahler A, Heinemann V, Held S, Alig AHS, Kasper S, Stintzing S, Trarbach T, Modest DP. Depth of response of induction therapy and consecutive maintenance treatment in patients with RAS wild-type metastatic colorectal cancer: An analysis of the PanaMa trial (AIO KRK 0212). Eur J Cancer. 2023 Jan;178:37-48. doi: 10.1016/j.ejca.2022.09.011. Epub 2022 Oct 25.

    PubMed 36399909

  • Modest DP, Karthaus M, Fruehauf S, Graeven U, Muller L, Konig AO, Fischer von Weikersthal L, Caca K, Kretzschmar A, Goekkurt E, Haas S, Kurreck A, Stahler A, Held S, Jarosch A, Horst D, Reinacher-Schick A, Kasper S, Heinemann V, Stintzing S, Trarbach T. Panitumumab Plus Fluorouracil and Folinic Acid Versus Fluorouracil and Folinic Acid Alone as Maintenance Therapy in RAS Wild-Type Metastatic Colorectal Cancer: The Randomized PANAMA Trial (AIO KRK 0212). J Clin Oncol. 2022 Jan 1;40(1):72-82. doi: 10.1200/JCO.21.01332. Epub 2021 Sep 17.

    PubMed 34533973

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Maintenance Chemotherapy, Panitumumab (Within maintenance phase) and mFOLFOX6 (Within re-induction phase) in people with Metastatic Colorectal Cancer, run by AIO-Studien-gGmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Until end of follow-up (24 months after randomization)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01991873, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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