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Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

Primary Purpose

Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cetuximab

capecitabine

gene expression analysis

microarray analysis

polymorphism analysis

reverse transcriptase-polymerase chain reaction

immunohistochemistry staining method

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Comprehensive Cancer Center
City of Hope Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.

Outcomes

Primary Outcome Measures

Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Full Information

NCT ID

NCT00538291

First Posted

October 1, 2007

Last Updated

August 19, 2014

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00538291

Brief Title

Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated early due to lack of efficacy.

Study Start Date

August 2005 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Genetic

Intervention Name(s)

gene expression analysis

Intervention Type

Genetic

Intervention Name(s)

microarray analysis

Intervention Type

Genetic

Intervention Name(s)

polymorphism analysis

Intervention Type

Genetic

Intervention Name(s)

reverse transcriptase-polymerase chain reaction

Intervention Type

Other

Intervention Name(s)

immunohistochemistry staining method

Primary Outcome Measure Information:

Title

Response Rate

Description

Time Frame

Assessment after every 2 cycles of treatment, up to 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Chung, MD

Organizational Affiliation

City of Hope Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

City of Hope Medical Group

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

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