A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cetuximab

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic 1st line colorectal cancer

Eligibility Criteria

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

Inclusion Criteria: Patients must have signed an IRB approved informed consent. Patients with histologically or pathologically documented, stage IIIB or IV adenocarcinoma of the colon or rectum. Patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease). Patients with tumors that are EGFR + by IHC staining. Patients with ECOG Performance status of 0 or 1. Patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal. Bone marrow function: absolute neutrophil count (ANC) > or = 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE, version 3) Grade 1. Platelets > or = 100,000/uL (CTCAE Grade 0 - 1). Renal function: creatinine < or = 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1. Hepatic function: bilirubin < or = 1.5 x ULN, CTCAE Grade 1. AST < or = 2.5 x ULN, CTCAE Grade 1. Exclusion Criteria: Patients who received prior chemotherapy for metastatic disease. Prior adjuvant therapy with 5FU/LV and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study. Patents who received prior oxaliplatin. Patients who received prior cetuximab or other therapy which specifically and directly targets the EGF pathway. Patients with acute hepatitis. Patients with active or uncontrolled infection. Patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure. Prior allergic reaction to chimerized or murine monoclonal antibody therapy. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent. Patients with peripheral neuropathy > grade 1

Sites / Locations

Veeda Oncology

Outcomes

Primary Outcome Measures

To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer.

Secondary Outcome Measures

To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen

Full Information

NCT ID

NCT00251485

First Posted

November 8, 2005

Last Updated

August 20, 2008

Sponsor

Veeda Oncology

Collaborators

Bristol-Myers Squibb, Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00251485

Brief Title

A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

Official Title

A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Veeda Oncology

Collaborators

Bristol-Myers Squibb, Sanofi

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease. Primary Study Endpoint: To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer. Secondary Study Endpoint(s): To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen.

Detailed Description

The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate compared to IFL (irinotecan and bolus 5-FU plus leucovorin ) and IROX (irinotecan plus oxaliplatin. Cetuximab has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone.30,31 Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to a 5-FU/LV/oxaliplatin-based regimen (FOLFOX) used in the 1st line setting may lead to the development of more treatment options for subjects with advanced colorectal cancer. This is a Phase II, open label, non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIB/IV, EGFR+ adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease. Patients will receive a modified FOLFOX 6 regimen (5-FU, leucovorin, and oxaliplatin) every 2 weeks in combination with cetuximab given weekly. Patients will be evaluated for response and progression-free survival. Overall survival will also be evaluated, as well as the safety profile of the regimen.

6. Conditions and Keywords

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

Colorectal Cancer

Keywords

Metastatic 1st line colorectal 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

82 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

Cycle 1: 400 mg/m2 (given as a 2-hour infusion) on Day 1, then 250 mg/m2, Day 8 (given as a 1-hour infusion) subsequent cycles:250 mg/m2, Day 1 and Day 8 (given as a 1-hour infusion)

Primary Outcome Measure Information:

Title

To assess the response rate, progression-free survival, and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer.

Time Frame

unk

Secondary Outcome Measure Information:

Title

To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 + cetuximab regimen

Time Frame

unk

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients must have signed an IRB approved informed consent. Patients with histologically or pathologically documented, stage IIIB or IV adenocarcinoma of the colon or rectum. Patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease). Patients with tumors that are EGFR + by IHC staining. Patients with ECOG Performance status of 0 or 1. Patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal. Bone marrow function: absolute neutrophil count (ANC) > or = 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE, version 3) Grade 1. Platelets > or = 100,000/uL (CTCAE Grade 0 - 1). Renal function: creatinine < or = 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1. Hepatic function: bilirubin < or = 1.5 x ULN, CTCAE Grade 1. AST < or = 2.5 x ULN, CTCAE Grade 1. Exclusion Criteria: Patients who received prior chemotherapy for metastatic disease. Prior adjuvant therapy with 5FU/LV and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study. Patents who received prior oxaliplatin. Patients who received prior cetuximab or other therapy which specifically and directly targets the EGF pathway. Patients with acute hepatitis. Patients with active or uncontrolled infection. Patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure. Prior allergic reaction to chimerized or murine monoclonal antibody therapy. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent. Patients with peripheral neuropathy > grade 1

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Boccia, MD

Organizational Affiliation

Veeda Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veeda Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77042

Country

United States

Colorectal Cancer

About this trial

Eligibility Criteria

Sites / Locations

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

Learn more about this trial