Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Cetuximab for Elderly Patients With mCRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718808
Recruitment Status : Terminated (FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU.)
First Posted : October 31, 2012
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic colorectal cancer (mCRC).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Drug: Capecitabine Phase 2

Detailed Description:

Primary endpoint: If in a treatment arm the number of patients alive and without progression at 12 weeks is 17 or more, this arm will be considered promising, otherwise not promising. Additionally, a two-sided 95% confidence interval for the difference in Progression free survival (PFS) rates between the two arms will be calculated.

Secondary endpoints and patient characteristics:

  • Laboratory values may be expressed as the absolute values (continuous variables) or/and as grading (ordinal categorical variables).
  • Generally for each categorical variable the results will be summarized by frequencies and percentages. For response rates 95% Clopper-Pearson confidence intervals will be calculated.
  • For each adverse event, the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades
  • For each continuous variable the results will be summarized by descriptive statistics.
  • Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95% confidence intervals.
  • All analysis will be done by treatment arm.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer. A Multicenter Phase II Trial
Actual Study Start Date : November 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm A: Cetuximab
Cetuximab 500 mg/m2 every 2 weeks
Drug: Cetuximab
Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
Other Name: Erbitux

Active Comparator: Arm B: Cetuximab and Capecitabine

Cetuximab 500 mg/m2 every 2 weeks plus Capecitabine 1000 mg/m2 (*) bid d1-14 every 3 weeks

* 750 mg/m2 if creatinine-clearance 30-50 ml/min

Drug: Cetuximab
Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
Other Name: Erbitux

Drug: Capecitabine
Capecitabine 1000 mg/m2 bid p.o. (750 mg/m2 if creatinine clearance 30-50 ml/min according to Cockroft-Gault formula, on days 1-14 every 3 weeks, restart on day 22
Other Name: Xeloda

Primary Outcome Measures :
  1. Progression free survival in week 12 [ Time Frame: in week 12 ]

    A progression event is defined as (whichever occurs first):

    • Progressive disease (PD) assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    • Death of any cause
    • Starting of second line treatment
    • No tumor assessment 85 days (+/- 7 days) after registration which shows stabilisation or response Patients without tumor assessment at week 12 but with a later assessment showing absence of progression without subsequent treatment will be counted as a progression free at week 12

Secondary Outcome Measures :
  1. Quality of life (QL) [ Time Frame: Baseline, in week 7, 13 and 19 ]
  2. Adverse events (CTCAE v 4.0) [ Time Frame: Adverse events are assessed by Common terminology criteria for adverse events (CTCAE) v4.0. From randomization until 30 days after end of treatment (estimated up to 2 years). ]
  3. Overall Response (OR) [ Time Frame: Before start of treatment. In week 13 and every 12 weeks up to 2 years. ]
  4. Progression free survival (PFS) [ Time Frame: PFS will be calculated sustained from randomization until documented PD or death, whichever occurs first (estimated up to 2 years). ]
  5. Overall Survival (OS) [ Time Frame: Overall survival will be calculated from randomization until death (estimated up to 2 years). ]
  6. Overall treatment utility (OTU) (predefined composite endpoint including clinical benefit, tolerability and acceptability of the treatment) [ Time Frame: Until week 19. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has given written informed consent before any trial specific treatment
  • Histological proven diagnosis of colorectal cancer, metastatic or inoperable advanced, not amenable to curative therapy
  • Measurable disease, defined as at least one lesion (outside of irradiated areas) that can be measured in at least one dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes) according to RECIST v1.1
  • Tumour with wild-type KRAS and wild-type BRAF gene
  • No previous systemic chemotherapy for metastatic disease (previous adjuvant chemotherapy is allowed if completed >6 months before randomization, previous rectal radio-chemo therapy if completed >1 month before randomization)
  • WHO performance status 0 or 1
  • Age >75 years; or: age ≥ 70 years with at least one of the following factors:
  • Any functional dependence as measured by Instrumental Activities of Daily Life (IADL). Significant comorbidity according to the Cumulative Illness Rating Scale for geriatric patients (CIRS-G; any severe comorbidity > grade 3 or a total score > 5 qualifies)
  • Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
  • Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) (unless known Gilbert-Meulengracht syndrome), aspartate aminotransferase (AST)<2.5xULN
  • Calculated creatinine clearance ≥ 30 ml/min. (according to the formula of Cockcroft-Gault)
  • Patient is able to swallow oral medication
  • Baseline Quality of Life forms have been completed

Exclusion Criteria:

  • Documented or suspected cerebral and/or leptomeningeal metastases (no cerebral baseline imaging required in asymptomatic patients)
  • Risk of rapid deterioration due to tumor symptoms or tumor complications
  • Synchronous or prior malignancy other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix, other malignancies unless disease free > 2 years
  • Prior anti-EGFR (Epidermal Growth Factor Receptor) antibody therapy
  • Severe or uncontrolled cardiovascular disease (e.g. acute coronary syndromes, cardiac failure NYHA (New York Heart Association) III or IV, clinically relevant myopathy, history of myocardial infarction within the last 12 months, significant arrhythmias)
  • Concurrent severe uncontrolled medical illness (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled infection, uncontrolled diabetes mellitus, active autoimmune disease)
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drug
  • Definite contraindications for the use of corticosteroids or antihistamines as premedication
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome or history of inflammatory intestinal disease, or other disease which could alter drug absorption
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QL forms, or interfering with compliance with oral drug intake
  • Any concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic approved product information
  • Concurrent treatment with other experimental drugs or other anti-cancer therapy and/or treatment in a clinical trial within 30 days prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718808

Layout table for location information
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Spitalzentrum Biel
Biel, Switzerland, CH-2501
Hopital Fribourgeois
Fribourg, Switzerland, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital Muensterlingen
Muensterlingen, Switzerland, 8596
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Klinik Hirslanden
Zurich, Switzerland, CH-8032
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Layout table for investigator information
Study Chair: Dirk Kienle, MD Kantonsspital Graubünden
Study Chair: Roger von Moos, MD Kantonsspital Graubünden
Study Chair: Ralph Winterhalder, MD Luzerner Kantonsspital
Study Chair: Dieter Köberle, MD Cantonal Hospital of St. Gallen
Layout table for additonal information
Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT01718808    
Other Study ID Numbers: SAKK 41/10
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
Metastatic Colorectal Cancer
Wild-type Metastatic
Phase II Trial
Elderly Patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological