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Study Summary No. DM00-329:.......Lung; CTRC(Translational Research)......Roy S. Herbst......Thoracic and Head and Neck Medical Oncology

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Study Summary Title

Study Summary Number:	DM00-329
Study Title:	PHASE II STUDY OF CETUXIMAB ANTI-EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ANTIBODY IN COMBINATION WITH DOCETAXEL IN PTS W/ RECURRENT OR METASTATIC NON-SMALL CELL LUNG CANCER

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Physician

New Patient Referral

Name:	Roy S. Herbst		Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:	Thoracic and Head and Neck Medical Oncology		Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:	713-792-6363 Contact us about clinical trials

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General Information

Disease Group:	Lung CTRC(Translational Research)		Supported By:	Imclone Systems, Inc.
Phase of Study:	Phase II		Return Visit:	Pts may participate in the study indefinitely as long as there is no disease progression or toxicity.
Treatment Agents:	RP 56976 Cetuximab		Home Care:	None
Treatment Loc:	outpatient
Estimated Length of Stay in Houston:	N/A

Description/ Intervention:	Unavailable

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Study Objectives / Outcomes

Unavailable

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Study Status Information

Study Activation / Registration Date:	04/24/2001
IRB Review and Approval Date:	11/15/2000
Study Type:	Therapeutic
Recruitment Status:	Terminated
Projected Accrual:	40

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Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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Inclusion Criteria:

Pt has uni-dimensionally measurable NSCLC. Immunohistochemical evidence of EGFR expression(>/=1+). If tumor tissue is not available for EGFR testing, biopsy will be done. EGFR expression must be confirmed prior to study entry. Karnofsky status >/=60 at study entry. Signed informed consent. Age >/= 18 yrs. Hematologic function: ANC ct >/= 1500/mm3, platelet ct>/=100,000/mm3, WBC >/=3000/mm3, Hgb >/= 9g/dL. Renal function: serum creatinine </= 1.5mg/dL & calculated creatinine clearance >/= 60cc/min. Pt is disease free from previously treated malignancy, other than disease under study,>3 yrs. History of previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix is OK. Pt has recurrent or progressive NSCLC with either present or prior histologic or pathologic confirmation of NSCLC. Pt has progressive disease within 3 mos after discontinuing one cytotoxic chemotherapy regimen (prior platinum therapy acceptable but neurotoxicity must be <= grade 1 at study entry) Hepatic function: serum creatinine <= 2.5XULN, alkaline phosphatase, AST and ALT <=1.5XULN Estimated life expectancy >= 6 mos. Pt, if a woman, agrees to use effective contraception if childbearing potential exists. Pt., if a man, agrees to use effective contraception. Pt has sufficient tumor tissue available for immunohistochemical determination of EGFr expression.

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Exclusion Criteria:

Pts have received prior docetaxel therapy. Pt have received prior chemo regimens </= 30 days prior to study entry. Pts has uncontrolled seizure disorder, active neurological disease, or Grade >/= 2 neuropathy (pts with meningeal or CNS involvement by tumor are elig.) Pregnant or lactating pts. Pt has received prior anti-epidermal growth factor receptor antibody therapy or small molecule therapy. Pt has received wide field therapy w/in 4 wks prior to the first infusion of Cetuximab. Pt may have local irradiation for the management of tumor-related symptoms. Pt has undergone major thoracic or abdominal surgery within 30 days (to allow for full recovery) prior to the first infusion of Cetuximab. Pt has a history of uncontrolled angina, arrhythmias, or congestive heart failure. Active systemic infection.

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Links

Registration Number:

Other Links:

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Results

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