FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

Key facts

Study ID: NCT01133990
Run by: Eisai Inc.
People needed: 5
Starts: 2010-03-04
Expected to finish: 2011-02-18
Last updated by the study team: 2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients may be entered in the study only if they meet all of the following criteria:
Male or female patient greater than or equal to 18 years of age;
Histologically or cytologically confirmed nonresectable locally advanced or metastatic colorectal adenocarcinoma;
Patients must have failed a first-line chemotherapy regimen for nonresectable locally advanced or mCRC (first-line bevacizumab is allowed). Patients randomized to the Phase Ib portion can have up to 3 total prior regimens (including adjuvant therapy in addition to treatment for advanced disease);
At least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria;
Life expectancy of > 3 months;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1;
Patients must have adequate renal function as evidenced by serum creatinine <2 mg/dL and creatinine clearance >50 mL/minute per the Cockcroft and Gault formula;
Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL (a hemoglobin <9.0 g/dL at Screening is acceptable if it is corrected to >9 g/dL by growth factor or transfusion prior to first dose);
Patients must have adequate liver function as evidenced by bilirubin <1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <3 X ULN (in the case of liver metastases, <5 X ULN). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase;
Blood pressure must be well-controlled (<140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment;
Females of childbearing potential must have a negative serum pregnancy test;
Females may not be breastfeeding; and
Ability to understand and willingness to sign a written consent.

You may not qualify if…

Patients will not be entered in the study for any of the following reasons:
Received chemotherapy, targeted therapy, radiotherapy, surgery, immunotherapy, or treatment in another clinical study within the 30 days prior to commencing study treatment or have not recovered from side effects of all treatment-related toxicities to Grade <1, except for peripheral neuropathy (Grade 1 and Grade 2 are permitted) and alopecia;
Previously received irinotecan or irinotecan derivatives;
Previously received anti-alpha 2 integrin therapy;
History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for >5 years;
Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
Are currently receiving any other anticancer treatment;
Palliative radiotherapy is not permitted throughout the study period;
Serious non-healing wound, ulcer, or active bone fracture;
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study;
Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Grade >2, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
Active hemoptysis (defined as bright red blood of
Current or recent use (within 7 days) of full-dose warfarin (except low-dose warfarin as required to maintain patency of preexisting, permanent indwelling IV catheters). For subjects receiving warfarin, International Normalization Ratio (INR) should be <1.5. Patients may have prophylactic use of low molecular weight heparin, however therapeutic use of heparin or low molecular weight heparin is not acceptable;
History of bleeding diathesis or coagulopathy;
Any history of cerebral vascular accident, transient ischemic attack or ≥ Grade 2 peripheral vascular disease, unless they have had no evidence of active disease for at least 6 months prior to randomization;
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1, unless affected area has been removed surgically;
Patients with organ allografts requiring immunosuppression;
Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or active hepatitis C positive;
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin;
Hypersensitivity to sulfonamide derivatives; or
Have any medical condition that would interfere with the conduct of the study.

Where it is running

Rocky Mountain Cancer Center - Midtown — Denver, Colorado, United States
Summit Medical Group — Berkeley Heights, New Jersey, United States
Hematology Oncology Associates SJ P.A. — Mount Holly, New Jersey, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
North Coast Cancer Institute — Coffs Harbour, New South Wales, Australia
Sydney Haematology & Oncology Clinic — Hornsby, New South Wales, Australia
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
Royal Hobart Hospital — Hobart, South Australia, Australia
Queen Elizabeth Hospital — Woodville South, South Australia, Australia
Box Hill Hospital — Box Hill, Victoria, Australia
The Austin Hospital — Epping, Victoria, Australia
Newcastle Private Hospital — Merewether, Australia
Jawaharlal Nehru Cancer Hospital and Research Centre — Bhopal, Madhya Pradesh, India
Searoc Cancer Hosptial — Jaipur, Rajasthan, India
Gujarat Cancer & Research Institute — Ahmedabad, India
Kidwai Institute of Oncology — Bangalore, India
M. S. Ramaiah Memorial Hospital — Bangalore, India
Subodh Mitra Cancer Hospital and Research centre — Kolkata, India
Shatabdi Hospital — Nashik, India
Deenanath Mangeshkar Hospital and Research Center — Pune, India
Noble Hospital — Pune, India
Christian Medical College — Vellore, India

Full record on ClinicalTrials.gov

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