Medical treatment of patients with cancer in colon or rectum

Phase II study with temozolomide and capecitabine for patients with refractory colorectal cancer - TEM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002327-15-DK

Enrollment

Registered

2013-02-27

Start date

2013-02-27

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with refractory colorectal cancer MedDRA version: 16.1 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Temozolomide Pharmaceutical Form: Capsule INN or Proposed INN: TEMOZOLOMIDE Other descriptive name: TEMOZOLOMIDE Concentration unit: mg milligram(s) Concentration type: range Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven non-resectable adenocarcinoma of the colon or rectum. 2. Patients who progress and who have been previously treated with fluoropyrimine, irinotecan, oxaliplatin and cetuximab (if K-RAS wild type). 3. Age = 18 years old. 4. Performance status (WHO) 0-1. 5. Adequate bone-, liver and kidney function: hemoglobin > 6,0 µmol/l, neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/l, bilirubin = 1,5 x UNL (Upper Normal Limit), ALAT or ASAT = 5 x UNL, creatinine = 1,5 xUNL, PP % between 0.5 - 1.3, APTT =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: 1. Cytotoxic treatment or other experimental treatment within 2 weeks of inclusion. 8. Other serious disease (ie. heartdisease, AMI within 1 year or ongoing infection). 9. Patients who cannot follow treatment schedule or evaluation schedule. 10. Known hypersensitivity towards one of the study drugs. 11. Any condition or therapy which after the decision of the investigator can put the patient on risk or affect the end-points of the study. 12. Pregnant women or women who are lactating. Patients who are not using contraception.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate a new treatment regimen to patients witn refractory colorectalcancer ;Secondary Objective: "Not applicable";Primary end point(s): Primary end-point is progressionfree survival	—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end-points are: Survival (OS) Toxicity Response rate	—

Countries

Denmark

Contacts

Public ContactDet Nationale Koordinationsudvalg v

Det Nationale Koordinationsudvalg vedr. eksperimentel kræftbehandling

456541 2921

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026