ICE CREAM: The Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Patients with G13D Mutatio

Phase 1

• Conditions: metastatic colorecal cancer; MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003638-18-IT
• Lead Sponsor: AGITG (Australasian Gastro - Intestinal Trial Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-29
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder or intra/extrahepatic bile ducts with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy;
2.K-RAS wild-type oncogene;
3.Uni-dimensional measurable disease as assessed by CT scan (RECIST v1.1 criteria).
4.Patients must have received no prior chemotherapy or biological therapy for advanced disease;
5.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment;
6.WHO performance status 0, 1 or 2;
7.Estimated life expectancy of at least 12 weeks;
8.Patient compliance and geographic proximity that allows adequate follow-up;
9.Adequate organ function including the following:
a.Adequate bone marrow reserve: absolute neutrophil count (ANC) of greater than or equal to 1.5 x109/L, platelet count of greater than or equal to 100 x109/L, and haemoglobin of greater than or equal to 9 g/dL.
b.Hepatic: AST and ALT less than 5 x upper limit of normal (ULN); bilirubin less than 2 x ULN; in patients with obstructive jaundice and bilirubin greater than or equal 2 x ULN, internal or external biliary drainage should be performed before enrollment. Patients should be enrolled only if bilirubin declines to greater than or equal 2 x ULN.
c.Renal: creatinine less than 1. 5 x ULN and calculated creatinine clearance greater than or equal to 50 mL/min, calculated according to the Cockcroft formula.
10.Signed informed consent from patient or legal representative.
11.Patients available to complete study requirements (visits, tests, evaluations and follow-up procedures) in a timely manner.
12.Male and female patients with reproductive potential must use a reliable contraceptive method if appropriate (eg, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Females with childbearing potential must have a negative urine pregnancy test within 7 days prior to study enrolment.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol;
2.Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment;
3.Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy, especially uncontrolled biliary tract infections;
4.Poorly controlled diabetes mellitus;
5.Interstitial lung disease
6.Any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator;
7.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception
8.Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
9.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception.
10.Documented brain metastasis.

Study & Design

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