Therapy for metastatic colorectal cancer

Phase 1

• Conditions: This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in mCRC.; MedDRA version: 20.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000016864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003217-41-AT
• Lead Sponsor: Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-06
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Untreated wild-type RAS metastatic colorectal cancer patients
Previous adjuvant therapy must have been completed = 1 year before therapy initiation.
Measurable disease with CT or MRI
ECOG performance status of 0-2
Adequate tissue to evaluate for genotyping
Adequate organ function
Hematologic:
Absolute neutrophil count > 1,500/µL
Hemoglobin >9 mg/dl
Platelet count >100,000 /µl
Renal:
Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 0 ml/min
Epatic:
Serum bilirubin < 1.5 mg/dl

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Creatinine clearance of below 30 ml/min
Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
Other known co-morbidity with the potential to dominate survival
Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
Pregnant or breast feeding women
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Study & Design

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