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

Vrije Universiteit Medisch Centrum0 个研究点目标入组 151 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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

•Subjects who meet the following criteria at the time of screening will be
•* 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.

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