A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)

NCT00589667 | Completed Phase 2 Results

• 1 other identifier: 06-087
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; GEMCITABINE; PEMETREXED; ALTIMA; epidermoid/squamous cell; carcinoma; pharynx; larynx; paranasal sinus; head/neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response

  To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2 years

Secondary Outcomes (1)

• Median Overall Survival

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.

Drug: Pemetrexed plus Gemcitabine

Interventions

Pemetrexed plus Gemcitabine DRUG

Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed. Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed. For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist.

Also known as: Alimta, LY231514

Treatment

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 microscopically confirmed epidermoid/squamous cell carcinoma (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous cell carcinoma unknown primary.
• Patients must have recurrent or metastatic disease which is not amenable to curative-intent therapy with surgery or radiation.
• No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease setting are permitted.
• Patients must be at least 18 years of age.
• Karnofsky Performance status must be ≥ 70%.
• Disease must be measurable by RECIST criteria.
• At least 4 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
• Prior radiation therapy to ≤ 25% of bone marrow is allowed. Prior radiation to the whole pelvis and/or brain is not allowed.
• Adequate organ function
• Patients of childbearing potential must have a negative test for pregnancy at time of enrollment based on a urine or serum pregnancy test. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
• Patient must reside in geographic proximity to MSKCC for adequate follow-up during treatment, per investigator discretion.
• Patients must sign an informed consent document.

You may not qualify if:

• Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar).
• Pregnancy or breast-feeding.
• Serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
• History of any brain metastases.
• Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
• Patients will be excluded if they will be unable to hold use of nonsteroidal antiinflammatory agents (NSAIDS) with short elimination half lives

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma; Laryngeal Diseases; Squamous Cell Carcinoma of Head and Neck

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: David Pfister, MD
• Organization: Memorial Sloan-Kettering Cancer Center

pfisterd@mskcc.org

646-888-4232

Study Officials

• David G Pfister, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: September 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 2, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-03

Locations

US (1)