Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Vitamins

Cetuximab

Leucovorin

Levoleucovorin

Antineoplastic Agents, Immunological

Folinic Acid

IMO 2055 is a novel phosphorothioate oligodeoxynucleotide that is an agonist of Toll-like Receptor 9 (TLR9).

IMO-2055

given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.

FOLFIRI

Phil Breitfeld, MD

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.

There are two distinct parts in this study:

* Part 1: Dose escalation from IMO-2055
* Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored

* Part 1: Dose escalation of IMO-2055, including 3 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with FOLFIRI and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen.
* Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with FOLFIRI with cetuximab.

Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

Open-label Phase 1b Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

EMD Serono

Patients will be asked by a member of the research team if they would like to participate in this study evaluating patients' comprehension of the informed consent for the oncology treatment study that they are participating in. Patients will be consented and will be told that, at their next clinical visit, they will be given the questionnaire to complete. They will be given the option to complete the questionnaire on site after being given the document or have the ability to mail the completed questionnaire into the research office once completed. If the questionnaire is not returned within 2-weeks, the participant will be approached again during their normal clinical visit and asked if they still wish to participate in this study.

All patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study.

Questionnaire

Andrew Schumacher

The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.

Obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. The development of the informed consent has been necessitated out of abuses committed in the name of medicine.

Informed consents have become increasing lengthy and complex. It is not unusual for an Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will utilize the QuIC-A survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. The QuIC-A survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent.

Investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.

Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?

Comprehension of the important elements of the informed consent forms using questionnaire

Effectors of patient comprehension using questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer	NCT00719199	Colorectal Canc...	IMO-2055 Cetuximab FOLFIRI	18 Years -	EMD Serono
Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?	NCT01772511	Cancer Oncology Proble...	Questionnaire	18 Years -	Brown University
Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer	NCT00719199	Colorectal Canc...	IMO-2055 Cetuximab FOLFIRI	18 Years -	EMD Serono

Spots Global Cancer Trial Database for prior therapy