MDACC Study Summary 2005-0082 (Archived)

Study Summary
No. 2005-0082:.......Head And Neck......Edward Kim......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2005-0082

Study Title:	A Phase I Dose Escalation Study of Pemetrexed in Patients with Advanced Head and Neck Squamous Cell Cancer

Physician

New Patient Referral



Name:	Edward Kim	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 I	Return Visit:	Participants will return to the clinic every 3 weeks.

Treatment Agents:	Pemetrexed	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of Alimta (pemetrexed) that can be given with or without dexamethasone in patients with HNSCC. The safety and effectiveness of this combination will also be studied.

Study Objectives / Outcomes

Primary Objective
● To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone)

Secondary Objectives
●To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity.
●To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.

Study Status Information



Study Activation / Registration Date:	09/12/2005

IRB Review and Approval Date:	04/06/2005

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 must have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesions and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx.

2) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.

3) Patients have received one or more chemotherapy regimens.

4) Age >/= 18 years.

5) Life expectancy of greater than 3 months.

6) No acute intercurrent illness or infection.

7) ECOG performance status </= 2 (Karnofsky >/= 60%)

8) Laboratory parameters: WBC >3,000/mL; Neutrophils >1,500/mL; Hemoglobin >8g/dL; Platelets >100,000/mL; Bilirubin <1.5 times the upper limit of normal; Serum creatinine: within normal institutional limits; ALT/AST < 3 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, except in known hepatic metastasis, wherein ALT/AST may be </= 5 x ULN

9) Creatinine clearance: The standard Cockcroft and Gault formula or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl for enrollment or dosing. The same method used at baseline should be used throughout the study. No dosage adjustment is needed in patients with CrCl >/= 45 mL/min.

10) Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.

11) Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1) Acute intercurrent illness or infection

2) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

3) Patients who are receiving any other investigational agents

4) Patients who have known brain metastases

5) Patients who have signs or symptoms of acute infection requiring systemic therapy.

6) Patients having a history of non-melanoma skin cancer, or other malignancies, treated less than 5 years or more prior to the current tumor

7) Patients requiring total parental nutrition with lipids.

8) Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.

9) Patients refusing to sign the informed consent.

10) Histology other than squamous cell carcinoma.

11) Inability or unwillingness to take folic acid or vitamin B12 supplementation

12) Inability to take corticosteroids

13) Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (for short-acting NSAIDs) or 8-day period (for long-acting NSAIDs, such as piroxicam).

Links

Registration Number: NCT00507858
Study Information on Clinical Trials Registry (clinicaltrials.gov)