Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01172470
First received: July 28, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine 1-year survival of previously irradiated Head and Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and daily radiotherapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Primary objective is to determine 1-year survival of previously irradiated Head/Neck Cancer patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed by concomitant pemetrexed, carboplat [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2005
Study Completion Date: July 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    4 doses of induction chemotherapy every 2weeks, IV (in the vein)
    Drug: Pemetrexed

    Induction Chemotherapy:

    4 doses of induction chemotherapy every 2weeks(Days 1, 15, 28, and 42), through an infusion for approximately 10 minutes.

    Chemoradiotherapy:

    Day 1,22, and 43through IV infusion over a period of 10 minutes

    Drug: Carboplatin

    Chemoradiotherapy:

    Day 1, 22 and 4 through IV infusion over a period of 1 hour.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All previously irradiated patients with recurrent head and neck cancer with no clinically measurable distant disease or those patients in whom distant disease was of low volume and local and regional palliation is clinically warranted. Low volume metastatic disease is defined as asymptomatic or minimally symptomatic disease that, according to physician judgment and without therapy for locoregionally recurrent disease, is unlikely to effect the subject's quality or quantity of life.
  • Histologic or cytological documentation of recurrent head and neck cancer requiring regional therapy.
  • Prior radiation therapy completed > 4 months before to study entry, if patients have recovered from all side effects grade 1.
  • Predominance of disease that is amenable to radiotherapy.
  • Measurable disease prior to induction chemotherapy.
  • Age >18 years
  • Life expectancy of greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky > 70%).
  • Patients must have normal organ and marrow function as defined below:

Leukocytes >3,000/ul Absolute neutrophil count >1,500/ul Platelets >100,000/ul Total bilirubin < 1.5X institutional upper limit of normal AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal Creatinine Clearance (CrCl) > 45 mL/min

The standard Cockcroft and Gault formula (based on actual weight) 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. Insufficient numbers of patients have been studied with creatinine clearance <45 mL/min to give a dose recommendation. Therefore, pemetrexed should not be administered to patients whose creatinine clearance is <45 mL/min.

Although ibuprofen and other non-steroidal inflammatory drugs (NSAID) can be administered with pemetrexed in patients with normal renal function (creatinine clearance 80 mL/min), caution should be used when administering NSAID concurrently with pemetrexed to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). Patients with mild to moderate renal insufficiency should avoid taking NSAID with short elimination half lives (e.g. ibuprofen) for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAID with longer half lives, all patients taking these NSAID should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. If concomitant administration of an NSAID is necessary, patients should be monitored closely for toxicity, especially myelosuppression, renal, and gastrointestinal toxicity.

  • The presence of a significant infection or another severe complicating medical illness may constitute a contraindication to entrance on this protocol.
  • Pregnancy is an absolute contraindication for this treatment protocol.
  • Ability to understand and the willingness to sign a written informed consent document
  • Ability to swallow vitamins and dexamethasone or willingness to use a feeding tube to ingest these agents

Exclusion Criteria:

Previously untreated patients are not eligible

Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Patients may not be receiving any other investigational agents.

History of allergic reactions attributed to compounds of similar chemical composition agents used in the study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172470

Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60653
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Ezra Cohen, MD The University of Chicago Medical Center
  More Information

Additional Information:
No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01172470     History of Changes
Other Study ID Numbers: 13881B
Study First Received: July 28, 2010
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Recurrent head and neck cancer
larynx, lip, oral cavity and pharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 01, 2014