AzTrials
AzTrials

Colorectal Cancer MetastaticPhase 3NCT01249638

Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC

A Phase 3 study testing Capecitabine, Bevacizumab and Irinotecan in people with Colorectal Cancer Metastatic, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Capecitabine, Bevacizumab and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteGermany
Study dates
Dec 2010to Dec 2016
Phase
Phase 3
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

  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Stage IV disease.
  • ECOG 0-1.
  • Patients considered suitable for application of chemotherapy.
  • Age 18 - 75 years.
  • In- or outpatient treatment.
Show all 12Show fewer
  • Estimated life expectancy > 3 months.
  • Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start.
  • Effective contraception.
  • Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl, platelets >= 100.000/µ, and hemoglobin >= 9g/dl. Bilirubin <= 1,5x upper limit of normal (ULN). ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN. Serum creatinine <= 1,5x ULN.
  • No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start. Operation sequels need to be completely healed. Major operations must not be expected at time of study begin, except for potential secondary resection of liver metastases. In case of secondary resection of liver metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
  • No relevant toxicities due to prior medical treatment at time of study entry.

Who cannot join

  • primary resectable metastases
  • heart failure Grade III/IV (NYHA-classification)
  • Prior treatment directed against the epidermal growth factor receptor (EGFR).
  • Prior treatment with bevacizumab.
  • Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back > 6 months prior to study entry.
  • Experimental medical treatment within 30 days prior to study entry.
Show all 26Show fewer
  • Known hypersensitivity reaction to any study medication.
  • Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).
  • Known or suspected cerebral metastases.
  • Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.
  • Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
  • Abdominal or tracheo-esophageal fistulas, gastrointestinal perforation within 6 months before study entry
  • Symptomatic peritoneal carcinosis.
  • Severe chronic wounds, ulcera or bone fracture.
  • Uncontrolled hypertension.
  • Severe proteinuria (nephrotic syndrome).
  • Arterial thromboembolic events or hemorrhage within 6 months prior to study entry (except tumor bleeding surgically treated by tumor resection).
  • Bleeding diatheses or coagulopathy.
  • Full dose anticoagulation.
  • Known DPD-deficiency (special screening not required).
  • Known glucuronidation-deficiency (special screening not required).
  • Contraindication with irinotecan
  • Medical history of other malignant disease within 5 years prior to study entry, except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
  • Known alcohol or drug abuse.
  • Medical or psychiatric condition which contradicts participation of study.
  • Limited legal capacity.

Trial locations and contacts

1 site in 1 country.

Volker Heinemann, Prof. Dr. contact

+49 89 7095 0

volker.heinemann@med.uni-muenchen.de

Germany1 site, 1 recruiting

  • University of Munich - Klinikum der Universitaet Muenchen

    Munich, 81377

    Volker Heinemann, Prof. Dr. med., +49 89 7095 0, volker.heinemann@med.uni-muenchen.de

    Clemens Giesse, Dr. med., +49 89 7095 0, clemens.giessen@med.uni-muenchen.de

    Recruiting

Other trials in Germany

About this study

Official title: Randomized, Open, Multicenter Phase III Study With Capecitabine Plus Bevacizumab Versus Capecitabine Plus Irinotecan Plus Bevacizumab as First-line Therapy in Patients With Metastatic Colorectal Cancer

Patient with multiple metastases, not eligible for surgery, might not profit from intensive chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease control may be a better choice for first line treatment. Therefore this study investigates the combination of capecitabine and bevacizumab versus the combination of capecitabine, bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is time-of-failure strategy (TFS) comparing both treatment arms.

Keywords
Bevacizumab, Capecitabine, Irinotecan, mCRC

What participants receive

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

  • CapecitabineDrug

    Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21

  • BevacizumabDrug

    Bevacizumab: 7.5 mg/kg day 1 q day 21

  • CapecitabineDrug

    Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21

  • IrinotecanDrug

    Irinotecan: 200 mg/m2 day 1 , q day 21

  • BevacizumabDrug

    Bevacizumab: 7.5 mg/kg day 1, q day 21

Study groups in NCT01249638
Study groupRoleWhat they receive
Cap+Bev until PD followed by CAPIRI +BevExperimentalCapecitabine + Bevacizumab In case of Progression Escalation to: Capecitabine + Irinotecan + Bevacizumab
Receives: Drug: Capecitabine; Drug: Bevacizumab
Capiri + BevActive comparatorCapecitabine + Irinotecan + Bevacizumab
Receives: Drug: Capecitabine; Drug: Irinotecan; Drug: Bevacizumab

What is being measured

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

  1. TFS

    Time of Failure Strategy

    Measured: 9 months

Secondary outcomes (1)

  1. ORR, OS, Quality of Life, PFS-1

    Measured: 36 months

Timeline

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

  1. First posted30 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2016 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01249638
Sponsor's protocol ID
ML22011
Status last verified
Nov 2010
First submitted
29 Nov 2010
Last updated
14 Mar 2011
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

  • Stahler A, Modest DP, Fischer von Weikersthal L, Kaiser F, Decker T, Held S, Graeven U, Schwaner I, Denzlinger C, Schenk M, Kurreck A, Heinrich K, Giessen-Jung C, Neumann J, Kirchner T, Jung A, Stintzing S, Heinemann V. First-line fluoropyrimidine plus bevacizumab followed by irinotecan-escalation versus initial fluoropyrimidine, irinotecan and bevacizumab in patients with metastatic colorectal cancer - Final survival and per-protocol analysis of the randomised XELAVIRI trial (AIO KRK 0110). Eur J Cancer. 2022 Sep;173:194-203. doi: 10.1016/j.ejca.2022.06.019. Epub 2022 Aug 5.

    PubMed 35940054

  • Stahler A, Heinemann V, Schuster V, Heinrich K, Kurreck A, Giessen-Jung C, Fischer von Weikersthal L, Kaiser F, Decker T, Held S, Graeven U, Schwaner I, Denzlinger C, Schenk M, Neumann J, Kirchner T, Jung A, Kumbrink J, Stintzing S, Modest DP. Consensus molecular subtypes in metastatic colorectal cancer treated with sequential versus combined fluoropyrimidine, bevacizumab and irinotecan (XELAVIRI trial). Eur J Cancer. 2021 Nov;157:71-80. doi: 10.1016/j.ejca.2021.08.017. Epub 2021 Sep 8.

    PubMed 34507244

  • Heinrich K, Modest DP, Ricard I, Fischer von Weikersthal L, Decker T, Kaiser F, Graeven U, Uhlig J, Schenk M, Freiberg-Richter J, Peuser B, Denzlinger C, Giessen-Jung C, Stahler A, Michl M, Held S, Jung A, Kirchner T, Stintzing S, Heinemann V. Gender-dependent survival benefit from first-line irinotecan in metastatic colorectal cancer. Subgroup analysis of a phase III trial (XELAVIRI-study, AIO-KRK-0110). Eur J Cancer. 2021 Apr;147:128-139. doi: 10.1016/j.ejca.2021.01.025. Epub 2021 Feb 27.

    PubMed 33647548

  • Modest DP, Fischer von Weikersthal L, Decker T, Vehling-Kaiser U, Uhlig J, Schenk M, Freiberg-Richter J, Peuser B, Denzlinger C, Peveling Genannt Reddemann C, Graeven U, Schuch G, Schwaner I, Stahler A, Jung A, Kirchner T, Held S, Stintzing S, Giessen-Jung C, Heinemann V; XELAVIRI/AIO KRK0110 Investigators. Sequential Versus Combination Therapy of Metastatic Colorectal Cancer Using Fluoropyrimidines, Irinotecan, and Bevacizumab: A Randomized, Controlled Study-XELAVIRI (AIO KRK0110). J Clin Oncol. 2019 Jan 1;37(1):22-32. doi: 10.1200/JCO.18.00052. Epub 2018 Nov 2.

    PubMed 30388045

  • Giessen C, von Weikersthal LF, Hinke A, Stintzing S, Kullmann F, Vehling-Kaiser U, Mayerle J, Bangerter M, Denzlinger C, Sieber M, Teschendorf C, Freiberg-Richter J, Schulz C, Modest DP, Moosmann N, Aubele P, Heinemann V. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: the AIO KRK 0110 trial/ML22011 trial. BMC Cancer. 2011 Aug 23;11:367. doi: 10.1186/1471-2407-11-367.

    PubMed 21861888

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Bevacizumab and Irinotecan in people with Colorectal Cancer Metastatic, run by Ludwig-Maximilians - University of Munich at 1 site 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 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Volker Heinemann, Prof. Dr. (+49 89 7095 0, volker.heinemann@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TFS (time frame: 9 months). 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 NCT01249638, which also lists 6 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 14 Mar 2011; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in