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A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79

OUTLINE: This is a multi-center study.

Week 1 (day 1):

- Cetuximab 400mg/m2

Week 2 (Cycle 1, Day 1):

- Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.

Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.

Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6

Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly
until PD or excess toxicity

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks


- ANC > 1,500/mm3

- Platelets > 100,000/mm3


- Bilirubin less than or equal to the upper limit of normal (ULN)

- Aspartate aminotransferase (AST) < 1.5 X ULN. AST may be < 5 X ULN for patients with
liver metastases

- Alkaline phosphatase < 5 X ULN


- Calculated creatinine clearance > 45 mL/min (by Cockcroft-Gault)


- No significant history of uncontrolled cardiac disease (i.e., uncontrolled
hypertension, unstable angina, and congestive heart failure)


- Not specified

Inclusion Criteria:

- Histologic or cytologic diagnosis of NSCLC

- Recurrent or metastatic disease that is not amenable to curative therapyMeasurable
disease according to RECIST

- At least one prior platinum containing regimen for either locally advanced or
metastatic disease

- Prior chemotherapy must be completed at least 21 days prior to being registered for
protocol therapy and the subject must have recovered from the acute toxicity effects
of the regimen

- Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory
agents for a 5-day period

- Prior radiation therapy allowed to < 25% of the bone marrow

- Negative pregnancy test

Exclusion Criteria:

- No active infection that in the opinion of the investigator would compromise the
subject's ability to tolerate therapy.

- No serious concomitant systemic disorders that would compromise the safety of the
subject or compromise the subject's ability to complete the study, at the discretion
of the investigator.

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the subject has
been disease-free for at least 2 years.

- No major thoracic or abdominal surgery within 30 days prior to being registered for
protocol therapy.

- No current breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Food and Drug Administration

Study ID:

HOG LUN04-79



Start Date:

May 2005

Completion Date:

December 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Texas Oncology Cancer CenterAustin, Texas  78731
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Elkhart ClinicElkhart, Indiana  46515
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Greenebaum Cancer CenterBaltimore, Maryland  21201