MDACC Study Summary 2003-0919 (Archived)

Study Summary
No. 2003-0919:.......Head And Neck......Merrill S. Kies......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2003-0919

Study Title:	PHASE II TRIAL OF INDUCTION THERAPY WITH CETUXIMAB (C225) AND CARBOPLATIN/PACLITAXEL CHEMOTHERAPY IN PREVIOUSLY UNTREATED PATIENTS WITH ADVANCED (STAGE IV) HEAD & NECK SQUAMOUS CELL CARCINOMA

Physician

New Patient Referral



Name:	Merrill S. Kies	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Med	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

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will come to MDACC weekly for treatment and evaluation.

Treatment Agents:	Carboplatin Cetuximab Paclitaxel	Home Care:	None.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospitalization required.

Description/
Intervention:

The goal of this clinical research study is find out if Paraplatinā
(carboplatin) and Taxolā (paclitaxel) given with the new drug Erbituxā
(cetuximab or C225) will help to control advanced squamous cell carcinoma of
the head and neck. The side effects of this combination will also be
studied. In addition, this study will look at recurrence of tumors in people
treated with this combination and will see what effect these drugs have on
their quality of life.

Study Objectives / Outcomes

Primary Objectives:

To increase the clinical/radiographic complete response rate after induction chemotherapy from 30% (expected with carboplatin / paclitaxel) to 50%.
To determine the toxicity of carboplatin/paclitaxel and cetuximab.

Secondary Objectives:

To determine patterns of tumor recurrence in patients treated with carboplatin/paclitaxel and cetuximab.
To determine duration of response, time to progression, and survival in patients treated with carboplatin/paclitaxel and cetuximab.
To investigate quality of life in patients treated with chemotherapy and cetuximab.
To evaluate the effects of induction chemotherapy in combination with cetuximab on biological markers that could serve as surrogates for response and predictors of long term outcome.

Study Status Information



Study Activation / Registration Date:	01/31/2005

IRB Review and Approval Date:	11/19/2003

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

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.

Inclusion Criteria:

1) Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx.

2) Patients should have stage IV disease, stage T0-4 N2b/2c/3 M0 (for nasopharynx patients, stage N1 disease is eligible). Measurable disease by RECIST is required.

3) Patients with stage Tx primary disease are eligible if there is N2b/3 adenopathy.

4) Karnofsky performance status of >/= 80 or ECOG PS 0-1

5) Age > 16 years

6) Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm3 and platelet count of > 100,000 cells/mm3; adequate hepatic function with bilirubin </= ULN, SGOT and SGPT may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4x ULN if SGPT and SGOT are normal. Patients who have both SGPT and SGOT > 1.5 ULN and alkaline phosphatase > 2.5 x ULN are not eligible. Normal PT/PTT and normal serum calcium (without intervention) are required.

7) Creatinine clearance > 40 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 CrCl female = 0.85 x (CrCl male)

8) Patients should have no serious acute or chronic co-morbid condition, or acute infection.

9) Patients must sign a study-specific informed consent form.

Exclusion Criteria:

1) Histology other than squamous cell carcinoma.

2) Evidence of distant metastases (below the clavicle) by clinical or radiographic means.

3) Karnofsky performance status < 80 or ECOG>1

4) Prior chemotherapy, within the previous 3 years.

5) Prior radiotherapy to the head and neck.

6) Prior cetuximab therapy, prior therapy with any other drug that targets the EGFR pathway, or prior therapy with a murine or chimeric monoclonal antibody.

7) Initial surgical resection rendering the patient clinically and radiologically disease free.

8) Simultaneous primary invasive cancers.

9) Patients with another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free).

10) Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.

11) WOCBP using a prohibited contraceptive method.

12) Women who are pregnant or breastfeeding.

13) Women with a positive pregnancy test on enrollment or prior to study drug administration.

14) Refusal to sign the informed consent.

15) Pre-existing peripheral neuropathy CTCAE grade 2 or worse.

Links

Registration Number: NCT00301028
Study Information on Clinical Trials Registry (clinicaltrials.gov)