EUCTR2012-002327-15-DK
Active, not recruiting
Phase 1
Phase II study with temozolomide and capecitabine for patients with refractory colorectal cancer - TEM
ConditionsPatients with refractory colorectal cancerMedDRA version: 16.1Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsCapecitabine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with refractory colorectal cancer
- Sponsor
- Odense University Hospital
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 1\.5 x UNL.
- •6\. Signed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
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.
Outcomes
Primary Outcomes
Not specified
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