Cetuximab in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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 carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in treating patients with advanced solid tumors.

Key facts

Study ID

NCT00376727

Run by

University of California, Davis

People needed

27

Starts

2004-12-01

Expected to finish

2007-12-01

Last updated by the study team

2010-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Davis Cancer Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.