Treatment optimization of cetuximab in patients with metastatic colorectal cancer based on tumour uptake of 89Zr-labeled cetuximab assessed by PET - COLO CETUX

Phase 1

• Conditions: advanced colorectal cancer; MedDRA version: 12.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2010-021943-41-NL
• Lead Sponsor: VU Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

- Advanced colorectal adenocarcinoma
- Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
- Age > 18 years.
- Histological or cytological documentation of cancer.
- Tumour material must be tested wild type for the K-Ras gene.
- Subjects have at least one measurable lesion outside the liver. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
- ECOG Performance Status of 0, 1 or 2
- Adequate liver and renal functions
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous exposure to an anti-EGFR therapy
- Significant skin condition interfering with treatment
- Insulin dependency
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
- Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.
- Major surgery within 28 days of start of study drug.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified