Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

cetuximab

irinotecan hydrochloride

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven refractory advanced colorectal carcinoma Must have 1 of the following: Stable disease after receiving a minimum of 12 weeks of irinotecan Disease progression at any time after receiving an irinotecan containing regimen No prior chemotherapy for colorectal carcinoma during the interval between the irinotecan containing regimen and study entry Bidimensionally measurable disease Index lesions must be outside prior radiation ports Epidermal growth factor receptor (EGFr) expression (1+ or greater) must be confirmed prior to study entry Patients who have no tumor tissue available for immunohistochemical assay of EGFr testing undergo biopsy of accessible tumor No meningeal or CNS involvement by tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN ALT and AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No clinically significant cardiac disease No serious arrhythmias No significant conduction abnormalities Neurologic: No uncontrolled seizure disorder No active neurologic disease No grade 2 or worse neuropathy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics Recovered from any toxicities No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 months since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery except diagnostic biopsy Other: At least 1 month since prior investigational agents

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EgFR antibody

Arm Description

Outcomes

Primary Outcome Measures

Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan.

Secondary Outcome Measures

Determine the safety and toxicity profile of this regimen in these patients.

Assess the quality of life of patients treated with this regimen.

Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen

Full Information

NCT ID

NCT00005076

First Posted

April 6, 2000

Last Updated

April 10, 2013

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005076

Brief Title

Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer

Official Title

Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Chemotherapy in Patients With Advanced Colorectal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

October 1999 (undefined)

Primary Completion Date

July 2005 (Actual)

Study Completion Date

July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of cetuximab and irinotecan in treating patients who have advanced colorectal cancer that has not responded to previous treatment.

Detailed Description

OBJECTIVES: I. Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan. II. Determine the safety and toxicity profile of this regimen in these patients. III. Assess the quality of life of patients treated with this regimen. IV. Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified by response to irinotecan based chemotherapy regimen (stable disease vs disease progression). Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on days 8, 15, 22, 29, and 36. Patients receive irinotecan IV over 90 minutes (beginning 1 hour after completion of cetuximab infusion) at the same regimen (dosage and frequency) on which the patient became refractory to irinotecan therapy. Irinotecan is administered at a higher dose on days 1 and 22 OR at a lower dose on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with unacceptable toxicity to irinotecan may continue on cetuximab maintenance therapy alone at the discretion of the protocol investigator and sponsor. Quality of life is assessed before initiation of study therapy, at the completion of each course, and then at 4 weeks after completion of study. Patients are followed at 4 weeks. PROJECTED ACCRUAL: Approximately 110 patients (55 per strata) will be accrued for this study within 7 months.

6. Conditions and Keywords

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

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EgFR antibody

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Primary Outcome Measure Information:

Title

Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan.

Time Frame

baseline to 40 weeks

Secondary Outcome Measure Information:

Title

Determine the safety and toxicity profile of this regimen in these patients.

Time Frame

baseline to 40 weeks

Title

Assess the quality of life of patients treated with this regimen.

Time Frame

baseline to 40 weeks

Title

Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen

Time Frame

baseline to 40 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven refractory advanced colorectal carcinoma Must have 1 of the following: Stable disease after receiving a minimum of 12 weeks of irinotecan Disease progression at any time after receiving an irinotecan containing regimen No prior chemotherapy for colorectal carcinoma during the interval between the irinotecan containing regimen and study entry Bidimensionally measurable disease Index lesions must be outside prior radiation ports Epidermal growth factor receptor (EGFr) expression (1+ or greater) must be confirmed prior to study entry Patients who have no tumor tissue available for immunohistochemical assay of EGFr testing undergo biopsy of accessible tumor No meningeal or CNS involvement by tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN ALT and AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No clinically significant cardiac disease No serious arrhythmias No significant conduction abnormalities Neurologic: No uncontrolled seizure disorder No active neurologic disease No grade 2 or worse neuropathy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab Chemotherapy: See Disease Characteristics Recovered from any toxicities No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 months since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery except diagnostic biopsy Other: At least 1 month since prior investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert F. LoBuglio, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Study Chair

Colorectal Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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