Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer (SoMore)

Study Description

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Brief Summary:

Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: chemotherapy	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	97 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer
Study Start Date :	February 2011
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Capecitabine & Sorafenib; Sorafenib 200mg in the morning,400mg in the evening; escalation to 400mg twice daily after 1 cycle, Oral, Continuous dosing Capecitabine 850mg/m2 twice daily, Oral Days 1-14, weeks 1-2	Drug: chemotherapy; sorafenib 600mg/day capecitabine 1250 mg/m²/day; Other Names: Xeloda; Nexavar

Outcome Measures

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Primary Outcome Measures :

1. Overall survival at 6 months fixed endpoint [ Time Frame: 6 months ]

   The 2 primary co-endpoints are :

   1. To obtain a preliminary assessment about the activity of the combination by estimating overall survival of the study population at a fixed time point (6 months)
   2. To compare as an exploratory analysis the overall survival of metabolic responders versus non-responders.

Secondary Outcome Measures :

1. To estimate the Progression Free Survival (PFS) distribution of the study population [ Time Frame: 12 months ]
2. To determine the objective response rate of the study population as assessed by standard imaging [ Time Frame: 12 months ]
3. To describe the adverse reactions associated with the study regimen in the study population. [ Time Frame: 12 months ]
4. To determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response. [ Time Frame: 12 months ]
5. To determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression un-der the latest prior regimen administered to the patient, with overall survival and progression-free [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
• All standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab, and panitumumab) are allowed as administered therapy before study entry. No more than two lines of treatment for metastatic or recurrent disease are allowed, except for patients with KRAS-wt tumors, for which third line with anti-EGFR agents is allowed.
• Age over 18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status ≤ 1.
• Participants must have normal organ and marrow function as defined below:
• Leukocytes > 3,000/mcL
• Absolute neutrophil count > 1,500/mcL
• Platelets > 100,000/mcL
• total bilirubin within 2 × normal institutional limits
• AST/ALT/PAKL levels < 5 × institutional upper limit of normal
• creatinine within 2 × normal institutional limits or creatinine clearance > 35mL/min
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.

• Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Participants may not be receiving any other experimental agents.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or capecitabine.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months, or major surgery within four weeks.
• Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because sorafenib and capecitabine are antitumor agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with sorafenib or capecitabine, breastfeeding should be discontinued if the mother is treated with sorafenib or capecitabine. These potential risks may also apply to other agents used in this study.
• Uncontrolled Diabetes
• FDG PET/CT negative lesions or non metabolically assessable lesions (to small <2cm) at the base line FDG PET/CT
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Contacts and Locations

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Locations

Belgium
Cliniques Universitaires Saint Luc
Woluwe Saint Lambert, Bruxelles, Belgium, 1200
Universiteit Ziekenhuis Antwerpen
Antwerpen, Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Hopital Erasme
Brussels, Belgium, 1070
Entité Jolimontoise
La Louviere, Belgium
Hopitaux St Joseph
Liege, Belgium, 4000
CHU Ambroise Paré
Mons, Belgium, 7000

Sponsors and Collaborators

Jules Bordet Institute

Erasme University Hospital

INDC Entité Jolimontoise

Centre Hospitalier Chretien

Universiteit Antwerpen

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Hospital Ambroise Paré Paris

Investigators

Principal Investigator:	Alain Hendlisz, MD	Jules Bordet Institute

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hendlisz A, Deleporte A, Delaunoit T, Maréchal R, Peeters M, Holbrechts S, Van den Eynde M, Houbiers G, Filleul B, Van Laethem JL, Ceyssens S, Barbuto AM, Lhommel R, Demolin G, Garcia C, El Mansy H, Ameye L, Moreau M, Guiot T, Paesmans M, Piccart M, Flamen P. The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer. PLoS One. 2015 Sep 30;10(9):e0138341. doi: 10.1371/journal.pone.0138341. eCollection 2015.

Responsible Party:	Jules Bordet Institute
ClinicalTrials.gov Identifier:	NCT01290926 History of Changes
Other Study ID Numbers:	EudraCT 2010-023695-91
First Posted:	February 7, 2011
Last Update Posted:	February 24, 2016
Last Verified:	February 2016

Keywords provided by Jules Bordet Institute:

advanced chemorefractory colorectal cancer; sorafenib; capecitabine; FDG-PET; early metabolic response

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Capecitabine; Sorafenib	Niacinamide; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs