Clinical trial NCT01289821: First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
Official title: An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-02-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged ≥ 18 years
* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
* At least 1 measurable lesion as per RECIST version 1.1
* Unresectable or unlikely becoming resectable metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended \> 6 months before screening and recurrent disease was documented.
* Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
* Uncontrolled hypertension
* Subjects with symptoms, signs, or history of brain metastases
* Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks of start of study treatment
* Sensory neuropathy (\> CTCAE Grade 1), unresolved toxicity \> CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia

Primary outcomes:
measure: Objective Response (OR)
timeFrame: From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
measure: Progression-free Survival (PFS)
timeFrame: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
measure: Disease Control (DC)
timeFrame: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
measure: Duration of Response (DOR)
timeFrame: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
measure: Duration of Stable Disease (DOSD)
timeFrame: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Concord
country: Australia
state: New South Wales
city: Woodville South
country: Australia
state: South Australia
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Oldenburg
country: Germany
state: Niedersachsen
city: Herne
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Napoli
country: Italy
state: Campania
city: Genova
country: Italy
state: Liguria
city: Ancona
country: Italy
state: Marche
city: Santander
country: Spain
state: Cantabria
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Glasgow
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R, Hacker UT, Kohne CH, Kornacker M, Boix O, Lettieri J, Krauss J, Fischer R, Hamann S, Strumberg D, Mross KB. Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study. Ann Oncol. 2013 Jun;24(6):1560-7. doi: 10.1093/annonc/mdt056. Epub 2013 Mar 13.