Status:
COMPLETED
Cetuximab in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 c...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of cetuximab in patients with advanced solid tumors. Secondary * Evaluate the safety and tolerability of this drug in these patients. * D...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Histologically or cytologically proven advanced solid tumors not curable by surgery, radiation therapy or standard chemo-, immuno-, or hormonal therapy. A specific primary cancer need not have been identified (i.e., unknown primary is eligible).
- Patients must have received at least one prior regimen (chemotherapy and/or radiation) for metastatic disease. There is no limit to the number of prior therapies.
- Any prior chemotherapy must have been completed at least 4 weeks prior to start of study therapy. Previous radiation therapy must have been completed at least 2 weeks prior to start of study therapy. All side effects of prior therapy must be resolved prior to the start of study therapy.
- Patients with ZUBROD performance status 0-2 (see Appendix 1).
- Patients must have measurable disease or evaluable disease.
- Patients must have an estimated survival of at least 3 months.
- Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids for at least 4 weeks.
- Patients \>/= 18 years of age.
- Patients of reproductive potential must agree to use an effective contraceptive method while on treatment and for 3 months afterward as the effects of cetuximab on the unborn fetus are unknown.
- Patients must have adequate hematologic function defined as: ANC \>/= 1,500/mm3, platelets \>/= 100,000/mm3.
- Patients must have adequate hepatic function defined as SGOT \</= 3 x institutional UNL and serum bilirubin \</= 2.0 mg/dL.
- Patients must have adequate renal function defined as a serum creatinine level \</= 1.6 mg/dL or a calculated creatinine clearance of \>/= 40 ml/min.
Exclusion
- Female patients cannot be pregnant or breastfeeding as the effects of cetuximab on the unborn fetus are unknown. Documentation of a negative pregnancy test prior to treatment is required for all women of reproductive potential.
- Uncontrolled intercurrent illness including but not limited to ongoing infection or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- Patients with symptomatic brain metastasis or still requiring steroids.
- Patients who have received prior cetuximab therapy, prior therapy with any other drug that targets the EGF receptor (including, but not limited to, Iressa, Tarceva, Herceptin, CI1033, etc.), or prior therapy with a monoclonal antibody.
- Patients who have received prior chemotherapy within 4 weeks or radiation therapy within 2 weeks prior to the start of study therapy.
- Prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy.
- Patients may not receive any other chemotherapy, radiation therapy, or biologic therapy while on study.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00376727
Start Date
December 1 2004
End Date
December 1 2007
Last Update
March 29 2010
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817