Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment
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Purpose
RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: cetuximab Drug: capecitabine Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Duration of overall survival (median and 1-year rate) [ Designated as safety issue: No ]
- Progression-free survival (median) [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Tolerance to therapy [ Designated as safety issue: Yes ]
| Enrollment: | 13 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| Study Chair: | Stephen I. Shibata, MD | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stephen I. Shibata, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00538291 History of Changes |
| Other Study ID Numbers: | CDR0000567432, P30CA033572, CHNMC-05033 |
| Study First Received: | October 1, 2007 |
| Last Updated: | December 22, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by City of Hope Medical Center:
|
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Capecitabine |
Fluorouracil Cetuximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013