Clinical trial NCT00954876: Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
Official title: Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Translational Genomics Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.


Eligibility criteria: Inclusion Criteria

* Metastatic colorectal cancer
* Tumor classified WT KRAS
* At least 18 yrs of age
* ECOG PS 0,1 or 2
* Evidence of adequate organ function
* Measurable disease per RECIST criteria
* Have at least two of the following criteria:

  * Age \> 65 years
  * ECOG PS 1 or 2
  * Serum Albumin \< or equal to 3.5g/dL
  * Prior RT to abdomen or pelvis
  * Stopped first-line combination systemic chemotherapy \< 6 weeks duration

Exclusion Criteria

* Tumors classified as KRAS mutation
* Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
* Prior exposure to any biologic
* Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
* Known DPD deficiency
* Uncontrolled angina or a myocardial infarction within the previous 12 months
* Concurrent severe uncontrolled medical illness
* Known uncontrolled CNS metastases
* Bowel disease associated with chronic diarrhea
* Major surgery within 28 days

Primary outcomes:
measure: Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
timeFrame: 18 months
Secondary outcomes:
measure: To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
timeFrame: 18 months
measure: To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
timeFrame: 18 months
measure: To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
timeFrame: every three months
measure: To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.
timeFrame: 1 year after study closure
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Evergreen Hematology & Oncology
state: Washington
Study officials:
affiliation: Translational Genomics
name: Ramesh Ramanathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: