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CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

CA225103: A Phase II Study of a Combination of Cetuximab and Capecitabine in Patients With Metastatic Colorectal Cancer After Progression on Previous Fluoropyrimidine Containing Therapy


OBJECTIVES:

Primary

- Determine the response rate in patients with metastatic colorectal cancer treated with
cetuximab and capecitabine that progressed on prior fluoropyrimidine-containing therapy
comprising irinotecan with or without oxaliplatin.

Secondary

- To determine the progression-free survival and overall survival of patients treated
with this regimen.

- To determine the tolerance to therapy in these patients.

- To assess biological correlates of response in available tissue biopsies and blood
samples.

OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood collection periodically for correlative studies.
Samples are analyzed for expression of genes correlated with fluoropyrimidine responsiveness
via quantitation RT-PCR; degree of expression of EGFR via immunohistochemistry; and
expression pattern analysis via gene expression profiling and polymorphism.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of metastatic colorectal cancer

- Measurable disease

- Disease progression during prior fluoropyrimidine-containing therapy comprising
irinotecan with or without oxaliplatin

- Received standard first- and second-line irinotecan and oxaliplatin-based
therapy

- Patients who completed 1 prior treatment for metastatic disease but refused
standard second-line therapy are eligible

- Patients who's disease progressed within 6 months of previous therapy are
eligible

- EGFR negative patients allowed

- No untreated or uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- ALT ≤ 5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 5 times ULN

- Serum creatinine ≤ 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No serious intercurrent infections or medical problems

- No active or uncontrolled infections

- No significant history of uncontrolled cardiac disease, including any of the
following:

- Uncontrolled hypertension

- Unstable angina

- Myocardial infarction within the past 6 months

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased ejection fraction

- No prior severe infusion reaction to a monoclonal antibody

- No known dihydropyrimidine dehydrogenase deficiency or evidence of past
hypersensitivity to fluoropyrimidine

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No more than 2 prior treatments for metastatic colorectal cancer

- More than 2 weeks since prior therapy

- Prior radiotherapy allowed if < 30% of bone marrow involvement

- No other concurrent investigational agents

- No concurrent highly active antiretroviral therapy for HIV-positive patients

- No prior therapy that specifically and directly targets the EGFR pathway

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Stephen I. Shibata, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000567432

NCT ID:

NCT00538291

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010
City of Hope Medical GroupPasadena, California  91105