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

This study has been withdrawn prior to enrollment.

(Study has been terminated due to lack of accrual.)

Sponsor:

Collaborator:

ImClone LLC

Information provided by:

TGen Drug Development Services

ClinicalTrials.gov Identifier:

NCT00954876

First received: July 17, 2009

Last updated: January 27, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2009

Last Updated Date

January 27, 2012

Start Date ^ICMJE

August 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00954876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population [ Time Frame: every three months ] [ Designated as safety issue: Yes ]
To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy. [ Time Frame: 1 year after study closure ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Colorectal Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00954876

Other Study ID Numbers ^ICMJE

MED-P02-07003

Has Data Monitoring Committee

Responsible Party

Ramesh Ramanathan, M.D. Principal Investigator, TGen Drug Development Services

Study Sponsor ^ICMJE

TGen Drug Development Services

Collaborators ^ICMJE

ImClone LLC

Investigators ^ICMJE

Principal Investigator:

Ramesh Ramanathan, M.D.

TGen Drug Development Services

Information Provided By

TGen Drug Development Services

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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