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Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
panitumumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon 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 or cytologically confirmed colorectal carcinoma Diagnosed by fine-needle aspirate or tissue biopsy Metastatic disease No squamous cell carcinoma Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR Evidence of relapse within 12 months after last dose of adjuvant therapy Bidimensionally measurable disease Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry Must be 2+ or 3+ in at least 10% of evaluated tumor cells No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.2 mg/dL Cardiovascular: LVEF at least 45% by MUGA No myocardial infarction within the past year Other: HIV negative No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No chronic medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior EGFr-targeting agents or biological agents with antitumor activity Chemotherapy: See Disease Characteristics At least 30 days since prior systemic chemotherapy No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine) No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy Surgery: Not specified Other: At least 30 days since other prior anticancer therapy No prior investigational drug with potential antitumor activity No other concurrent investigational drugs

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039273
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
Official Title
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.
Detailed Description
OBJECTIVES: Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF. Determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients. Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
panitumumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed colorectal carcinoma Diagnosed by fine-needle aspirate or tissue biopsy Metastatic disease No squamous cell carcinoma Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR Evidence of relapse within 12 months after last dose of adjuvant therapy Bidimensionally measurable disease Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry Must be 2+ or 3+ in at least 10% of evaluated tumor cells No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.2 mg/dL Cardiovascular: LVEF at least 45% by MUGA No myocardial infarction within the past year Other: HIV negative No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No chronic medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior EGFr-targeting agents or biological agents with antitumor activity Chemotherapy: See Disease Characteristics At least 30 days since prior systemic chemotherapy No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine) No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma Endocrine therapy: Not specified Radiotherapy: At least 30 days since prior radiotherapy Surgery: Not specified Other: At least 30 days since other prior anticancer therapy No prior investigational drug with potential antitumor activity No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Randolph Hecht, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Meropol NJ, Berlin J, Hecht JR, et al.: Multicenter study of ABX-EGF monotherapy in patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1026, 256, 2003.
Results Reference
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Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

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