Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer

NCT00507858 | Completed Phase 1

• 1 other identifier: 2005-0082
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Squamous Cell Cancer; Alimta; Pemetrexed; Dexamethasone; HNSCC; Decadron

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Pemetrexed

  MTD for pemetrexed within each schedule of dexamethasone is defined as the highest dose level in which less than 2 instances of dose limiting toxicities (DLT) observed out of 6 treated participants.

  3 weeks

Study Arms (3)

Pemetrexed

EXPERIMENTAL

Starting dose 500 mg/m\^2 IV once every 3 weeks

Drug: Pemetrexed

Pemetrexed + IV Dexamethasone

EXPERIMENTAL

Pemetrexed Starting dose 500 mg/m\^2 IV once every 3 weeks + Dexamethasone 20 mg intravenous (IV) Day 1.

Drug: Pemetrexed; Drug: Dexamethasone

Pemetrexed + Oral Dexamethasone

EXPERIMENTAL

Pemetrexed starting dose 500 mg/m\^2 IV once every 3 weeks + Dexamethasone 4 mg orally twice daily for 3 Days.

Drug: Pemetrexed; Drug: Dexamethasone

Interventions

Pemetrexed DRUG

Starting dose of 500 mg/m\^2 IV Once Over 10 Minutes Every 3 Weeks

Also known as: Alimta, LY231514, MTA, Multitargeted Antifolate, NSC-698037

Pemetrexed; Pemetrexed + IV Dexamethasone; Pemetrexed + Oral Dexamethasone

Dexamethasone DRUG

Arm 2 = 20 mg IV On Day 1; Arm 3 = 4 mg oral (PO) Twice Daily for 3 Days

Also known as: Decadron

Pemetrexed + IV Dexamethasone; Pemetrexed + Oral Dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• Patients have received one or more chemotherapy regimens.
• Age \>/= 18 years.
• Life expectancy of greater than 3 months.
• No acute intercurrent illness or infection.
• ECOG performance status \</= 2 (Karnofsky \>/= 60%)
• Laboratory parameters: white blood count (WBC) \>3,000/mL; Neutrophils \>1,500/mL; Hemoglobin \>8g/dL; Platelets \>100,000/mL; Bilirubin \<1.5 times the upper limit of normal (ULN); Serum creatinine: within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 3 times institutional ULN if alkaline phosphatase is \< ULN, except in known hepatic metastasis, wherein ALT/AST may be \</= 5 times ULN
• 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.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Acute intercurrent illness or infection
• 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
• Patients who are receiving any other investigational agents
• Patients who have known brain metastases
• Patients who have signs or symptoms of acute infection requiring systemic therapy.
• Patients having a history of non-melanoma skin cancer, or other malignancies, treated less than 5 years or more prior to the current tumor
• Patients requiring total parental nutrition with lipids.
• Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent.
• Patients refusing to sign the informed consent.
• Histology other than squamous cell carcinoma.
• Inability or unwillingness to take folic acid or vitamin B12 supplementation
• Inability to take corticosteroids
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Pemetrexed; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Squamous Cell; Carcinoma

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Edward Kim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: September 1, 2005
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

US (1)