Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC

Phase 2

Completed

Conditions: metastatic colorectal cancer
advanced intestinal cancer
10017991

Registration Number: NL-OMON50209

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 151

Inclusion Criteria

Subjects are eligible if they meet the following 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 is required.
* Tumor material must be tested wild type for the K-RAS, N-RAS and B-RAF genes.
* Tumor lesions:
- Part 1: Subjects have at least one measurable lesion * 2 cm outside the
liver. Lesions must be evaluable by CT or MRI according to Response
Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Parts 2: Subjects have at least one measurable tumor lesion * 1 cm, including
liver tumor lesion. Lesions must be evaluable by CT or MRI according to
Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* ECOG Performance Status of 0, 1 or 2
* Adequate liver and renal functions
* Signed informed consent must be obtained prior to any study specific
procedures.
* Life expectancy * 12 wk

Exclusion Criteria

Subjects who meet the following criteria at the time of screening will be
excluded:
* Previous exposure to an anti-EGFR therapy
* Significant skin condition interfering with treatment
* 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 2 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1A:<br /><br>89Zr-cetuximab uptake in non-hepatic tumor lesions (corrected VOIs);<br /><br>Clinical benefit rate<br /><br><br /><br>Part 1B:<br /><br>89Zr-cetuximab uptake in non-hepatic tumor lesions with increased dosing of<br /><br>cetuximab (corrected VOIs).<br /><br><br /><br>Part 2:<br /><br>Association between CBR and early response evaluation using 18F-FDG PET.<br /><br><br /><br>CBR is defined as the sum of CR, PR and SD according to RECIST 1.1 at 3 months<br /><br>after treatment start.<br /><br>Corrected VOIs are defined as measurements in VOI corrected for background<br /><br>levels.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) The % uptake (of total injected) 89Zr-cetuximab in non-tumor liver tissue<br /><br>and hepatic tumor lesions (corrected VOIs).<br /><br>2) 18F FDG-PET uptake before and after 2 weeks of cetuximab/ panitumumab<br /><br>treatment.<br /><br>3) Grade of skin toxicity as measured by predefined criteria in a skin biopsy<br /><br>(collected untill july 2020).</p><br>