Cetuximab in Treating Patients With Advanced Solid Tumors

NCT00376727 | Completed Phase 1 DMC

• 6 other identifiers: CDR0000506089P30CA093373UCDCC-165BMS-CA225027200412499IMCL-8420
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of cetuximab

  December 2007

Secondary Outcomes (4)

• Safety and tolerability of cetuximab

  December 2007

• Potential predictors of response using correlative studies

  December 2007

• Correlation of efficacy of cetuximab with grade of skin rash

  December 2007

• Development of a detailed scale for assessing skin rash

  December 2007

Study Arms (1)

Phase I dose escalation study

EXPERIMENTAL

Biological: cetuximab; Genetic: molecular diagnostic method; Other: immunologic technique; Other: laboratory biomarker analysis

Interventions

cetuximab BIOLOGICAL

Dose level 0: cetuximab 400 mg/m2 week 1, 250 mg/m2 weekly; Dose level 1: cetuximab 400 mg/m2 week 1, 300 mg/m2 weekly; Dose level 2: cetuximab 400 mg/m2 week 1, 350 mg/m2 weekly; Dose level 3: cetuximab 400 mg/m2 week 1, 400 mg/m2 weekly

Also known as: IMC-C225, Erbitux

Phase I dose escalation study

molecular diagnostic method GENETIC

Tissue and Blood Specimens; IHC Methodology; IHC Scoring; K-RAS Mutation Analysis

Phase I dose escalation study

immunologic technique OTHER

Peripheral Blood Mononuclear Cells (PBMC)

Phase I dose escalation study

laboratory biomarker analysis OTHER

Cetuximab Pharmacodynamics

Phase I dose escalation study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Cetuximab; Molecular Diagnostic Techniques; Immunologic Techniques

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Study Officials

• Angela Davies, MD

  University of California, Davis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: December 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

US (1)