A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Chemo-based Therapy. - FLAMENCO
- Conditions
- Metastatic Colorectal AdenocarcinomaMedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2007-005639-26-GB
- Lead Sponsor
- Oxford BioMedica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1312
- Patients with histology/cytology confirmed colorectal adenocarcinoma
- Metastatic colorectal cancer
- No prior palliative chemotherapy
- Patient's informed consent obtained, signed and dated.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* Related to study methodology
- Age < 18 years old
- ECOG performance status > 2
- (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse.
- Treatment with an investigational agent within 4 weeks (6 weeks from immunotherapy) of study enrollment
- Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time to randomization
- Patients with resectable liver or lung metastasis (study treatment should not be administered with neo-adjuvant intent in case of resectable liver or lung metastases, or with adjuvant intent after surgery of liver or lung metastases)
- Known brain metastasis or leptomeningeal disease
- History of other neoplasm. Patients with a prior history of either non-metastatic non-melanoma skin cancers, or carcinoma in situ of the cervix, or other cancer cured by surgery, or small field radiation or chemotherapy = 5 years prior to randomization are eligible
- Life expectancy < 3 months
* Related to chemo-based therapy (biological functions within 8 days before the first cycle: repeat in-range results within the screening period may replace previous out of range results in applying there exclusion criteria)
- Absolute neutrophil count (ANC) < 1.5 x 10e9/L, hemoglobin < 8.5 g/dL, platelet < 75 x 10e9/L
- Bilirubin = 1.5 x ULN, ASL/ALT or alkaline phosphatase (AP) = 3.0 x ULN, or in case of liver involvement AST/ALT or AP = 5 x ULN
- Creatinine > 1.0 x ULN, except in case of creatinine > 1.0 x ULN and = 1.5 x ULN if calculated creatinine clearance = 60 mL/min
- Any other active illness such as uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease or clinically significant arrhythmias (grade 3-4)
* Related to TroVax
- Lymphocytes < 1 x 10e9/L
- Serious infection within 28 days prior to randomization
- History of hypersensitivity to vaccinia vaccination
- Known hypersensitivity to egg protein or neomycin
- Known positive test to human immunodeficiency virus (HIV) or any congenial or acquired immune deficiency, or active and/or requiring treatment hepatitis B or C
- Active eczema with lesions on the skin
- Prior history of organ transplantation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To compare overall survival (OS) with TroVax vs. Placebo in patients with metastatic colorectal cancer receiving chemo-based therapy in first line treatment.;<br> Secondary Objective: - To compare PFS between TroVax vs. Placebo arms.<br> - To compare Objective Response rate (ORR) between TroVax vs. Placebo arms.<br> - To assess the safety and tolerability of TroVax and Placebo arms.<br><br> + Exploratory:<br> - To assess the immunologic response (5T4 and MVA antibody titers and T-cells) in a subgroup of this patient population (in selected centers).<br> ;Primary end point(s): The primary efficacy endpoint is overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause. In absense of confirmation of death survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date.
- Secondary Outcome Measures
Name Time Method