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A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

NCT01057589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2013-09-18

Study results available
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Summary

The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Pemetrexed

Triplet Combination Therapy: 500 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles Maintenance Therapy: 500mg/m\^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity

DRUG

Cetuximab

Triplet Combination Therapy: 400 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m\^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles. Maintenance Therapy: 250 mg/m\^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity

DRUG

Cisplatin

Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.

DIETARY_SUPPLEMENT

Folic Acid

Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.

DIETARY_SUPPLEMENT

Vitamin B12

Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2012-10-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057589 on ClinicalTrials.gov