ABX-EGF in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Chemotherapy
This study is currently recruiting patients.
Sponsored by: |
Jonsson Comprehensive Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Monoclonal antibodies such as ABX-EGF 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 ABX-EGF in treating patients who have metastatic colorectal cancer that
has not responded to previous chemotherapy.
Condition
|
Treatment or Intervention |
Phase |
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer stage IV colon cancer recurrent rectal cancer Stage IV rectal cancer
|
Drug: panitumumab Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy
|
Phase II
|
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Monoclonal Antibody ABX-EGF in Patients With Metastatic Colorectal Cancer That Failed Prior Chemotherapy
Comprising Fluoropyrimidine, Irinotecan, and Oxaliplatin
Further Study Details:
OBJECTIVES: Primary
- Determine the objective response rate and duration of response through week 16 of study treatment in patients with metastatic
colorectal cancer treated with monoclonal antibody ABX-EGF after failing prior chemotherapy comprising fluoropyrimidine, irinotecan,
and oxaliplatin.
Secondary
- Determine the objective response rate throughout the study, time to response, duration of stable disease, time to disease
progression, time to treatment failure, and progression-free and overall survival time of patients treated with this drug.
- Determine change in patient-reported outcomes in patients treated with this drug.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once every other week (i.e., weeks 1, 3, 5, 7, etc.). Treatment
continues for 60 weeks in the absence of disease progression, unacceptable toxicity, or a human anti-human antibody response.
Quality of life is assessed at baseline, once monthly during study treatment, and 4 weeks after completion of study treatment.
Patients are followed at 4 weeks and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 5 months.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal adenocarcinoma
- Metastatic disease
- Diagnostic tissue obtained by tissue biopsy
- Documented radiographic evidence of disease progression during or after chemotherapy comprising fluoropyrimidine, irinotecan,
and oxaliplatin within the past 6 months
- Must have received at least 2, but no more than 3, prior chemotherapy regimens for metastatic colorectal cancer
- Bidimensionally measurable disease
- At least 20 mm by CT scan, MRI, or spiral CT scan
- Tumor expressing epidermal growth factor receptor by immunohistochemistry
- Staining must be positive in ≥ 10% of evaluated tumor cells
- No symptomatic brain metastases requiring treatment
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin ≤ 2 times ULN
Renal
Cardiovascular
- LVEF ≥ 45% by echocardiogram or MUGA
- No myocardial infarction within the past year
Pulmonary
- No interstitial pneumonitis or pulmonary fibrosis by CT scan
Other
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No allergy to the ingredients of the study drug or to Staphylococcus aureus protein A
- No chronic medical condition, unresolved complication, or laboratory abnormality that would preclude study participation
- No psychiatric illness that would preclude study compliance
- No other disorder that would preclude study consent or participation
- No other active malignancy within the past 5 years except basal cell carcinoma in situ of the cervix or surgically cured malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy
- More than 30 days since prior treatment with any approved antitumor small molecules or biologic agents of short (< 1 week)
serum and tissue half-life
- More than 3 months since prior experimental or approved proteins or antibodies
Chemotherapy
- See Disease Characteristics
- More than 30 days since prior systemic chemotherapy
- No prior chemotherapy for metastatic colorectal cancer except fluoropyrimidine, irinotecan, or oxaliplatin*
- Prior leucovorin calcium and levamisole allowed
- No concurrent chemotherapy NOTE: *Patients must have continued therapy until progressive disease was noted
Endocrine therapy
Radiotherapy
- More than 30 days since prior radiotherapy
- No prior radiotherapy to index lesions
- No concurrent radiotherapy
Surgery
Other
- More than 30 days since any other prior experimental agents
- More than 30 days since any other prior antitumor therapy
- No prior epidermal growth factor receptor (EGFR)-targeting agents
- No other concurrent investigational agents
- No other concurrent EGFR-targeting agents
Location
and Contact
Information
California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,
California,
90095-7187,
United States; Recruiting
Joel Randolph Hecht, MD
310-206-6909
Study chairs or principal investigators
Joel Randolph Hecht, MD, Principal Investigator, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000373839; UCLA-0402029-01; AMGEN-2003167
Record last reviewed:
June 2004
Record first received:
July 8, 2004
ClinicalTrials.gov Identifier:
NCT00087243Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17