Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

NCT00293579 | Completed Phase 2 Results DMC

• 1 other identifier: OSU-0482
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  Up to 3 years

Secondary Outcomes (3)

• Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer

  Up to 3 years

• Impact of Pemetrexed Chemotherapy on Quality of Life

  Baseline, End of Treatment [up to 3 years]

• Overall Survival

  Up to 2 years

Study Arms (1)

Pemetrexed

EXPERIMENTAL

pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

500 mg/m2 IV every 3 weeks for 6 cycles

Also known as: ALIMTA

Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Advanced, metastatic, or recurrent head and neck cancers
• Poor risk patients with ECOG performance status of 2

You may not qualify if:

• Prior treatment for recurrent or metastatic disease
• No clinical or radiological evidence of brain metatases
• Patients with bone only disease are not eligible
• Patients with pleural or peritoneal effusion as only manifestation of diesase

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Urba S, van Herpen CM, Sahoo TP, Shin DM, Licitra L, Mezei K, Reuter C, Hitt R, Russo F, Chang SC, Hossain AM, Frimodt-Moller B, Koustenis A, Hong RL. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer. 2012 Oct 1;118(19):4694-705. doi: 10.1002/cncr.27449. Epub 2012 Mar 20.

  PMID: 22434360 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

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

Results Point of Contact

• Title: Anterpreet Neki
• Organization: Ohio State University Comprehensive Cancer Center

Anterpreet.Neki@osumc.edu

614-257-2900

Study Officials

• Anterpreet Neki, M.D.

  Ohio State University

  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: February 15, 2006
• First Posted: February 17, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 10, 2020
• Results First Posted: March 10, 2016

Record last verified: 2020-01

Locations

US (1)