Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00954876
• Other study ID #: MED-P02-07003
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2022
• Source: Translational Genomics Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• capecitabine and cetuximab
Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks

Locations

Country	Name	City	State
United States	Evergreen Hematology & Oncology	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Translational Genomics Research Institute	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab		18 months
Secondary	To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab		18 months
Secondary	To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab		18 months
Secondary	To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population		every three months
Secondary	To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.		1 year after study closure